Dolmen Engineering Engagement Hub

Automation Engineer

Permanent

Full-time

Published date:

2022-12-08

Summary

Welcome to AbbVie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are recruiting an Automations and Control Systems Engineer to join our site in Ballytivnan, Sligo. The Automations and Control Systems Engineer will provide technical support and program management to all manufacturing operations and NPI’s throughout the site

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities as a Automations and Control Systems Engineer would be:

To provide technical support and program management to all manufacturing operations and NPI’s throughout the site.
To provide technical leadership of all control system activities in the pharmaceutical manufacturing facilities.
Ability to take active lead on control system validation activities during project start-up.
Project management of control system elements of continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects.
Project management and technical development of future integrations of the control systems, with planned MES/ERP/Data Historian (OSI PI) systems.
Life cycle management of the on-site control systems to Abbvie SLC & applicable regulatory requirements.
Provide technical support to all control system related issues. Tasks include, daily trouble shooting, optimisation, and documentation control.
Adheres to and supports all EHS & E standards, procedures and policies.
Identify opportunities and assist in leveraging of vendor qualification efforts, developing relationships with vendors, and act as Engineering representative for pre-approval of vendor documentation.

Education and Experience:

NFQ Level 8 Honors Bachelor’s Degree or Higher Diploma in a relevant technical discipline required.
3 years plus experience in an automation engineering role, with software development of PLC / DCS platforms for batch processing in a GMP pharmaceutical industry environment.
3 years plus experience of the 21 CFR Part 11 requirements for automated systems in the pharmaceutical industry.
3 years plus of Experience of plant start-ups and/or new product introductions to pharmaceutical facilities. Must be able to lead these activities in a start-up environment.
Experience in validation of control systems would be advantageous.
Experience in auditing and internal inspection would be advantageous.

So, are you ready to join our team?

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Utilities Project Manager

Permanent

Full-time

Published date:

2022-12-08

Summary

Who We Are:

Dolmen Engineering provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

Role Summary:

We are seeking an experienced Utilities Project Manager with 5+ years’ experience to join our expanding team and work on a leading pharmaceutical site based in Cork. The Utilities Project Manager will report to the Engineering Manager and be responsible for executing utility upgrade and retrofit projects.

What We Offer:

Competitive Salary	Bike to work scheme
Strong Pension Healthcare contribution Generous holiday allowance	Educational allowance Staff incentives Social Club

Duties:

Manage utility projects and equipment installation, commissioning, and qualification (depending on dark or clean system). Project values range 100k to 1.2million.
Liaising directly with engineering and maintenance teams in relation to all aspects of work onsite.
Development, review, and approval of technical information including scoping/tender documents, design documents, Safety Risk Assessments, Method Statements, and Commissioning documents.
Contractor Management throughout scoping, tendering, project execution and snagging/close-out
Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements.
Ensure alignment on Environment Health & Safety Standards, Engineering Standards, Utility System, Budgeting, Compliance focused.
Managing communication with client, staff, subcontractors, suppliers, and all relevant teams to ensure a quality project is delivered.
Ensure equipment and processes are engineered, maintained, and operated within all local, national, business codes and regulations.
Ensure the completion of projects within budgetary, regulatory, and time limits.
Ensure compliance to all Safety, regulatory GMP and non GMP requirements.
Develop and manage People, Safety, Quality, Delivery and Cost KPI’s
Review and prepare formal responses, complete periodic reviews and other compliance documentation aligned with the site.
Full project lifecycle cost control – developing tender/scoping documents, analysis of returns, contractor appointment and variation control.

Requirements:

Bachelor’s degree in an engineering discipline.
5+ years Engineering experience within a regulated environment, preferably in the pharmaceutical industry.
Experience of Operations and Installation of Clean and Black Utilities Systems ie Process Gasses, Compressed Air, Steam, Cooling Towers, Refrigerants, HVAC systems etc.
Knowledge of PM processes and tools through significant experience in a PM function.
Understanding of mechanical, electrical, control and automation, HVAC & clean Utility systems maintenance requirements.
Experience and proven ability of managing multiple projects simultaneously with varying values.
A compliance mindset for EH&S and Quality standards, regulations, and practices.
Be proficient in MS Project and knowledge on 3D software and SAP system.
Ability to work on own initiative and leading and executing projects from inception to completion
Self-motivated personality with the ability to make decisions.

What To Do Next:

Apply with your latest CV in strictest confidence and please indicate a time when you are free to be contacted. Alternatively, contact Juliana Tonetti directly on 0871733174 or @ juliana.tonetti@dolmenengineering.com

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Senior Process Engineer

Ireland

Permanent

Full-time

Published date:

2022-12-08

Summary

Who We Are:

Dolmen Engineering provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

Role Summary:

We are active seeking a Senior Process Engineer with 3-4 years experience to join our expanding team. Supporting the PMO and Design team on projects across the Life Sciences sectors, including Pharmaceutical, Bio-Pharmaceutical, and MedTech, the Senior Process Engineer will be responsible for all aspects of process design and development of solutions, working across Equipment, Utilities and Facility projects.

What We Offer:

Competitive Salary	Compressed week
Strong Pension Healthcare contribution Hybrid working lifestyle Generous holiday allowance	Educational allowance Staff incentives Social Club Bike to work scheme

Duties:

Leads all aspects of design, from Feasibility Analysis to Detailed Design, including PFD and P&ID development, process and equipment sizing, interconnecting pipe work and valve requirements.
Prepare material and utilities balances for the design throughout – flowrates, pressure, and temperature data.
Process data sheets and/or sketches for all process equipment items, giving process and dimensional data if appropriate,
Process data for Instrument data sheets, selection of instruments, Relief data sheets, line list and piping specifications.
Calculating the electrical requirements for the related electrical loads.
Coordination of design with other design disciplines and equipment suppliers.
Prepare Technical Data Specifications (TDS) based on the equipment sizing, codes & standards as applicable.
Participation in Technical and Safety reviews, HAZOP and FMEA facilitation.
Liaising with clients and vendors.
Develop specifications including URS, FRS, control philosophy, FDS and other project and process documentation.
Supporting the business development team in the preparation of technical proposals.
Assist with resource and spending forecasting and reporting out all costs monthly to client.
Installation supervision and commissioning of the installed items/systems.
Change control, project close out.
Review and assessment of user requirements and the preparation of Technical Queries to clarify client specifications.
Develop schedules / timelines and the management of all disciplines and overseeing deliverables
Coordinate Design, Specification, and selection of process equipment including:

Line hydraulics (Sizing), Pump sizing & evaluations.
Flow Orifice calcs.
Oxygen depletion calculations – Codes & standards as applicable
Safety Relief valve sizing- Codes and standards
Emergency relief valve calcs.- Codes and standards

Requirements:

Bachelor Engineering (B.E. Hons. or higher) in Process Engineering or similar.
At least 3+ years demonstrable experience within the life science industry.
Knowledge on the HAC (Hazardous Area Classification) drawings and ATEX requirements, PED (Pressure Equipment Directive) guidelines.
Knowledge of Codes & Standards of Process Equipment.
Be proficient in excel for the templates – Project/Process specific.
Proven ability to successfully manage the delivery of projects., acting in a Client facing role.
Be energetic and dynamic with excellent people management, interpersonal and communication skills to operate within a project delivery environment.
Ability to work on own initiative and leading and executing projects from inception to completion

What To Do Next:

Apply with your latest CV in strictest confidence and please indicate a time when you are free to be contacted. Alternatively, contact Juliana Tonetti directly on 0871733174 or @ juliana.tonetti@dolmenengineering.com

Read More Apply Now

Project Engineer

Manorhamilton, Sligo, Ireland

Contract

Full-time

Published date:

2022-12-02

Summary

Dolmen Engineering is urgently seeking a project engineer for a leading Pharmaceutical Company based in Sligo.

Primary Responsibilities:

To provide Engineering services to the plant, in order to maximise the availability of all API Process Equipment and Utilities.
To manage engineering projects within the API facility
To support the engineering teams in controlling uptime of process equipment and optimizing efficiencies both in equipment and process performance.
To support the Engineering team with the emphasis on continual operational improvements.
To provide process engineering support and technical trouble shooting within the API facility.
To improve the operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives.
To manage the execution of projects within the engineering group including specific Process Safety Projects. To support the provision of process safety initiatives to the site.
To liaise with Production to ensure equipment performance is maximized.
To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining trouble shooting, and installing/commissioning equipment.
To become the SME for all API Process Equipment and supporting Utilities.
Utilisation of SME knowledge to drive continual improvement of Process Equipment PM’s.
Oversee execution of Process Equipment PM’s and identify opportunities for improvement.
To provide engineering support and technical trouble shooting to all site operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives.
Leadership of process equipment commissioning and validation activities.
Identification and project management of continuous improvement projects. Work closely with all site functions and other departments to deliver these continuous improvement projects.
Preparation of feasibility studies and budget management for all assigned projects.
Management and negotiation of external contracts and contractors.
Support all major site initiatives and sites core goals.

Desired Skills and Experience

Education

Degree in a relevant Engineering Discipline

Experience

A minimum of 5 years’ experience in process engineering, with relevant experience of batch processing, automation, project management, commissioning and validation, equipment reliability and continuous improvement.
Working knowledge of distributed control systems, such as Delta V.
This is a hand-on role requiring a logical and structured approach to resolving day to day engineering issues typical of a live manufacturing environment.
Knowledge of cGMP and regulatory requirements relating to the Healthcare industry is required.
Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements.

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Production Lead

Permanent

Full-time

Published date:

2022-12-02

Summary

Job Title: Lead Manufacturing Biotech Associate-O4 Via the AgileOne Programme Supporting MSD Dunboyne

Start Date	Asap
Location	MSD Dunboyne, Piercetown, Co. Meath, A86 HD21
Duration	11 Months
Contract Type	Fixed Term Contract
Remote Role Y/N	No

Role Description

This role will be part of Manufacturing Self Directed work team/ Hub in the new state of the art single use

multi-product biotech facility in Dunboyne, County Meath, Ireland. The organisational structure at the site will

be based on self-directed work teams where decisions will be made at the level where the data exists.

The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and

collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the

manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with

a continuous improvement mindset. Ensure that objectives are effectively achieved, consistent with MSD’s requirements to ensure compliance, safety and provide a reliable supply to our customers.

Role Functions (Functions include, but are not limited to, the following)
Primary responsibilities include but not limited to: • Carry out and support operations to achieve assigned duties. • Deliver shift standard work for a team-based approach to batch progression. • Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture. • Conduct sampling/ in-process testing supporting the manufacturing and validation processes. • Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT). • Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements. • Provide coaching to the shift teams on the RFT approach to documentation. • Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices. • Initiate/ maintain housekeeping in all work areas. • Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate. • Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc. • Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required. • Coach and provide oversight on the shop floor to identify potential issues before they arise. • Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables. • Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies. • Lead straight-through document accuracy metrics and the development of a CI framework. • Support site functional initiatives to improve compliance status and operational efficiency of the site. • Run handover boards and provide key updates to shift leads for handover. • Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays. • Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable. • Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment. • Effectively manage and schedule equipment shutdowns. • Ensure resources are available, thereby minimizing downtime. Any other duties as and when assigned by the Manager.

Role Functions

(Functions include, but are not limited to, the following)

Primary responsibilities include but not limited to:

• Carry out and support operations to achieve assigned duties.

• Deliver shift standard work for a team-based approach to batch progression.

• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.

• Conduct sampling/ in-process testing supporting the manufacturing and validation processes.

• Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).

• Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.

• Provide coaching to the shift teams on the RFT approach to documentation.

• Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.

• Initiate/ maintain housekeeping in all work areas.

• Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.

• Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.

• Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.

• Coach and provide oversight on the shop floor to identify potential issues before they arise.

• Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.

• Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.

• Lead straight-through document accuracy metrics and the development of a CI framework.

• Support site functional initiatives to improve compliance status and operational efficiency of the site.

• Run handover boards and provide key updates to shift leads for handover.

• Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving,

CI projects and assist with the resolution of issues/ delays.

• Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.

• Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.

• Effectively manage and schedule equipment shutdowns.

• Ensure resources are available, thereby minimizing downtime.

Any other duties as and when assigned by the Manager.

Experience, Knowledge & Skills
General Competencies: • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices. • Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts. • Ability to think logically and be proactive under pressure. • Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving. Technical: • On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements. • Proficiency with automated systems such as Manufacturing Execution System (MES - PAS X), Systems Applications and Products (SAP), Delta V etc. • Knowledge of Lean methodologies. • Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures. • Familiar with plant equipment. • Training others and/ or leading hands-on or instructor-led training. • Ability to read, write and understand technical information.

Experience, Knowledge & Skills

General Competencies:

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices.

• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts.

• Ability to think logically and be proactive under pressure.

• Excellent trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving.

Technical:

• On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.

• Proficiency with automated systems such as Manufacturing Execution System (MES - PAS X),

Systems Applications and Products (SAP), Delta V etc.

• Knowledge of Lean methodologies.

• Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures.

• Familiar with plant equipment.

• Training others and/ or leading hands-on or instructor-led training.

• Ability to read, write and understand technical information.

Qualifications & Education
Minimum Education/ Experience: • Minimum of a Bachelors Level 8 degree in Science, Engineering or other Technical Discipline. • 5 years experience in a GMP environment. • 3 years experience in Biopharma industry, with direct experience of biologics manufacture. • Proven record of accomplishments in a regulated industry required • This role is a site based position. • This role will involve working shift, on a 24/7 basis.

Qualifications & Education

Minimum Education/ Experience:

• Minimum of a Bachelors Level 8 degree in Science, Engineering or other Technical Discipline.

• 5 years experience in a GMP environment.

• 3 years experience in Biopharma industry, with direct experience of biologics manufacture.

• Proven record of accomplishments in a regulated industry required

• This role is a site based position.

• This role will involve working shift, on a 24/7 basis.

Read More Apply Now

Automation Manager

Permanent

Full-time

Published date:

2022-12-02

Summary

Who We are:
Dolmen Engineering provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

We are seeking a Senior Automation Manager for a leading healthcare manufacturing based in Cavan.

The role:
Senior role responsible for developing and implementing Automation strategy across the site. The role will bring together the appropriate technology, process and workplace solutions in order to contribute to the overall Operations (Manufacturing, Plant Maintenance, Smart Factory and Quality).
This is a key role that will require excellent stakeholder management and influencing skills and will interact with all levels of the organisation ensuring competing priorities are managed objectively and in line with the overall business strategy.

Responsibilities:
• Acting as the primarily 'owner' for the Automation environment on the site, you will ensure that the environment grows in accordance with the Operational Technology Strategy.
• Develop and maintain the OT Strategy and Roadmap for the site including Industry and Smart Factory (digital) opportunities.
• Ensure that all projects involving OT elements adhere to the site strategy.
• Ensure that Third Party Suppliers, System Integrators and Service providers follow OT standards.
• Technical solution design and evaluation, delivery, commissioning, and validation.
• Accountable for the lifecycle management of infrastructure, applications & services.
• Develop and implement strategy for Retain, Retire and Replace applications.
• Responsible for the maintenance, compliance, and availability of the OT systems
Requirements:
• Bachelor’s Degree (preferably in Engineering or Computer Science) is required.
• 10+ years of business working experience in a technology function in operations / manufacturing environment.
• Experience in the delivery and management of automated systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88, S95 and PackML industry standards and appropriate development methodologies for utility, process and packing control systems.
• Experience dealing with a large portfolio of systems, projects and initiatives in the areas of Information Systems, Automation and Operations.
• Experience with automation systems in cGMP regulated manufacturing environments and will be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations and understand software system validation.
• Experience with Siemens PLC, SCADA and OSIsoft Pi Data Historian is desired.
• Demonstrated ability to run and lead service providers, remotely.
• Familiarity with continuous improvement and project management approaches, tools and phases.
• Exceptional ability to lead change using positive and collaborative methods.

Read More Apply Now

Engineering Manager

CN, IE

Permanent

Full-time

Published date:

2022-11-03

Summary

We are seeking for a Senior Engineering Manager to manage and execute complex projects in a highly regulated, quality-controlled food manufacturing environment based in Cavan.

The ideal candidate will support and establish with the Operations, Engineering, & EHS Managers the departmental goals, schedules and timetables for activities. Your collaborative attitude and interpersonal skills will help you thrive as an Engineering Manager.

Responsibilities

Models manufacturing and automated processes in the process area in order to maximise understanding within the function.
Oversight, coaching and capability development of the technical team within the Value stream that ensures that all new equipment is validated as per QA procedures.
Calculates and organizes all data for complex process flow sheets, including instrumentation and control considerations. Ensures proper sequence of operation and prepares specifications and operating instructions for processing equipment.
Plan and schedule work in accordance with plant demand and available manpower.
Conducts tests and measurements throughout stages of production to determine control over such variables as temperature, density, pressure and viscosity, etc.
Services, troubleshoots, and solves engineering problems with processes or equipment via a cross-functional structured problem-solving approach.
Ensures processes and procedures are in compliance with regulatory requirements.
May be responsible for corrective and preventive actions, and investigation management.
Develops, communicates, and implements operational plans for completing complex specialist projects in the area.
Takes pro-active action to resolve operational problems and minimize downtime.
Participates in selecting and managing the activities of contractors to ensure they are integrated into the relevant projects and the organization receives satisfactory standards of service.

Requirements

Bachelor’s Degree in Food Process Engineering or equivalent discipline.
Minimum of 10 years relevant experience in Engineering.
Experienced in highly Automated Manufacturing Environments with a solid understanding of pharma/food processing equipment is essential.
Prior experience in a Dairy/Food Process Engineering role is very desirable.
Knowledge of Spray drying operations and/or Evaporation is desirable.
Knowledge or experience in Thermal processing of Dairy based products is desirable.
Knowledge or experience in Powder conveying systems.
Knowledge or experience in ATEX rated environments and their constraints.

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Process Engineer

Permanent

Full-time

Published date:

2022-10-26

Summary

Primary Function

Key Responsibilities

To successfully manage and support Projects through all element of Project Lifecycle, from Design to Commercial Manufacturing
Provide Technical & Process Engineering Support to Operations, including Root Cause Analysis, Trouble Shooting and Continuous Improvement
Subject matter expert for all process on site.

To lead projects throughout entire lifecycle
To provide technical and engineering support, daily trouble shooting, optimisation and cost reduction.
Drive Equipment Uptime through reliability engineering and continuous improvement
Monitoring and analysis of Process Equipment data during the commercial manufacturing.
Identification and project management of continuous improvement projects.

Education/

Other (Refer to National Framework Qualification where possible)

Essential Requirements

Minimum degree qualification in a relevant engineering, science or technical discipline

Desirable Requirements

Masters Qualification in relevant technical discipline

Job Skills/ Experience Required

Technical/Business Knowledge -Job Skills/Experience Required

5 years’ experience in Biopharmaceutical Industry, including experience in Aseptic/Fill Finish area
Experience working with lean methodologies. Previous experience in lyophilization and sterilization operations preferable
Experience in new product introductions to Biologic facilities is desirable
Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
Experience in leading process/product specific deviations, NCR’s, CAPA etc
Understanding of equipment and process related validation activities (IOQ, PQ etc)

Cognitive Skills

The position requires proven problem-solving skills under the pressure. The position requires detailed evaluation of a number of viable solutions to each problem.
The position requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
Requires total commitment to quality and maintaining a high standard of work at all times.
Demonstrates the highest levels of integrity and a strong work ethic at all times.
Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required.
Understands and Supports the principles of Perfect Performance.

Ownership/Accountability

Every employee has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillars and AbbVie Ways of Work.
Lead and support successful introduction of NPI’s onsite.
Subject Matter Expert for the product onsite
Lead product and process specific investigation.
Supports and executes Commercial Product campaigns successfully
Shows a high level of tenacity to ensure closure of issues.
Partners with the EHS&E group and take project lead on process safety.
Demonstrates an ethos of Right First Time at all times.
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.

Influence/Leadership

May be required to lead Cross Functional Teams and cost improvement projects.
Develops and maintains close relationships with S&T and R&D.
Provide technical leadership to functional areas and collaborates with key stakeholders.
May provide leadership in sub projects related to commercial or NPI activities.

Decision Making/Impact

Expected to provide functional expertise to support daily operations.
Seeks Managers input when making decisions which affect the area.

Supervision Received

Operates in an environment which is largely self-managed but with supervision through the Technical Team Leader.
Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.

Supervision Provided

No direct reports.
May provide cross training and guidance to new department members.
May supervise and lead projects and develop training.

EHS Responsibilities

Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
Attend all required EHS training and medical surveillance programs;
Wear PPE as required.

	Printed Name	Signature	Date
Employee Approval
Supervisor/Manager Approval

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Commissioning and Qualification Engineer

Contract

Full-time

Published date:

2022-10-21

Summary

This is a CQV (Commissioning, Qualification and Validation) Engineer position which will be responsible for the authoring and execution of the Performance Qualification (PQ) documents on site equipment and utilities including HVACs, Downflow Booths, Autoclaves, CTUs, Gases and Steam. The role is a combination of hands-on execution in the field and validation SME support for the project.

Primary activities/responsibilities:

Plan and co-ordinate the performance qualification (PQ) activities for equipment and utilities in the BioNX project ensuring all projects are on schedule and meet the set timelines.
Effectively monitor and communicate the performance qualification activities and execution plan to other teams, project managers and key stakeholders.
Author, review and execute PQ protocols in line with Quality and Regulatory expectations
Author PQ reports in line with Quality and Regulatory expectations
Co-ordinate the day-to-day management of contractors where qualification activities are outsourced e.g. Temperature Mapping, HVAC qualification, Gas qualification, Autoclave qualification etc.
Manage performance qualification documentation, test scripts, qualification protocols, summary reports and risk assessments.
Perform validation SME reviews of vendor protocols.
Provide validation SME support for risk assessments and change controls.
Support the development of Standard Operating Procedures.

Key Behaviours:

Focus on Customers, Including Patients.
Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs Collaborate.
Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new Merck.
Act with Candour and Courage.
Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions Make Rapid, Disciplined Decisions.
Make timely decisions at the right level with the right data and support them once made. Drive Results.
Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
Demonstrate Ethics & Integrity.
Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies, and regulations; identify and address ethical issues without hesitation.

What skills you will need:

Experience developing validation documentation
Experience executing validation protocols
Experience closing out validation activities and writing validation reports
Project management experience a plus
Ability to analyse data and make recommendations
Experience in working with cross functional teams
Excellent report, standards, technical writing skills
Proficiency in Microsoft Office suite and job-related computer applications required
Level 8 degree in a Science, Engineering or Other related Technical discipline

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Production Supervisor

Tipperary

Permanent

Full-time

Published date:

2022-10-13

Summary

Who We Are:

Dolmen Engineering provides Project Management, Engineering Design, and Project resourcing services to the Pharmaceutical and Life Science Sectors. As a company we specialize in the design and delivery of process-driven projects across Ireland and internationally.

Role Summary:

The Production Supervisor will be responsible for providing team leadership to a group of employees committed to increased quality and productivity. Identifies and analyses problems, plans tasks and solutions. Provides guidance to team on development, performance and productivity issues. Reports to functional and/or organisation management on team accomplishments, achievements and productivity. This is a permanent position, based in Co. Tipperary.

Duties:

Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and co-ordinating the selection process with Human Resources (HR).
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
Monitors daily work operations and provides direction to predominantly non-exempt and entry level staff to achieve unit or departmental goals.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Interprets and executes policies that affect individuals within the assigned organisational unit or department.
Monitors compliance with company policies and procedures (for example (e.g.) compliance with Food and Drug Administration (FDA), British Standards Institution (BSI), Equal Employment Opportunities regulations etcetera (etc.)).
Develops work schedules for department by assessing priorities, workload and available resources.
Maintains personnel records (e.g., work schedules, vacation schedules/leaves and makes or directs modifications in the database to reflect actual changes.
May perform individual contributor tasks, especially in staff or professional units.

Requirements:

Level 7 qualification in a relevant discipline.
2+ years of related work experience, or an equivalent combination of education and work experience.
Experience in regulated environment.
Proven experience in monitoring costs of projects and human and material resources.
Ability to develop and identify new work processes and continuous improvement programme.

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