Process Engineering Lead

Dolmen Engineering are expanding their existing Process Design team and now require a Process Engineering Department Lead to support and lead projects from our Dublin office. This is a key role for the company.

Are you an experienced Process Engineer with the ability to support the management and execution of projects from initiation to closeout?

We have a fantastic opportunity for an ambitious Process Engineering Lead to join our growing team in Dublin.

With excellent people skills, you have a proven ability to work in partnership at all levels.

As Process Engineering Department Lead, you will lead and take ownership for stages of projects from concept to detailed design on projects largely within the Biopharmaceutical and Pharmaceutical industry.

Your responsibilities will include leading various stages of projects from concept to detailed design.

A key part of your role will be to support and mentor your team-members.

Duties

• Manage a team of Process Engineers, ranging from graduate to senior level.
  • Performance reviews
  • KPI’s
  • Project resourcing
  • CPD for team members
• Coordination of the Process Design Team to manage and achieve project deliverables and design optimisation.
• Delivery of agreed design scope within budget hours and schedule
• Design and specification of equipment and systems to current regulations and design standards.
• Selection/liaison with Suppliers for both standard and bespoke equipment
• Preparation of tender packages for process equipment
• Tender Bid Assessment both technical and commercial
• Technical input to project proposals.
• Technical input and support for Process Design Team
• Developing process solutions for new NPIs and new projects.
• Responsible for all project process deliverables
• Process calculations such as hydraulic calculations and relief device sizing
• Interfacing with client design team/end user
• Lead Technical and Safety reviews
• Design of process and utilities - preparation of PFDs, P&IDs, equipment sizing calculations.
• Development URS, FRS, P&ID’s, and other project and process drawings and documentation.
• Ensure the compliance of design in accordance with all codes and standards, policies and guidelines
• Coordination of design with other design disciplines and equipment suppliers.

Requirements

• Bachelor Engineering (B.E. Hons. or higher) in Chemical Engineering or equivalent
• Have 8+ years in Bio/Pharma/API Design
• Awareness of process safety engineering and process safety management
• Previous participation in HAZOPs and Design Risk Assessments
• Significant design experience in the Life Sciences sector
• Ability to work on own initiative.
• Proven ability to successfully manage the delivery of projects., acting in a client facing role on Equipment, Facility and Utility design projects
• Proven ability to lead/manage a team of process engineers
• Energetic and dynamic with excellent people management, interpersonal and communication skills to operate within a project delivery environment.

Desirable Requirements

• Proven experience in project management capacity, executing projects from inception to completion.

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.

Project Manager

Dolmen Engineering is immediately seeking a Project Manager for our Life Science client site in Sligo.

The Project Manager will join our Contract Services team, and support our client's PMO function, in managing numerous packages of works across utilities, facilities, and equipment projects. The successful candidate will have experience in Facility and Utility projects.

Job Specification:

• Project Management of the Site Capital Project including management of project scope, schedule, and budget.
• Manage project utility and equipment installation, commissioning, and qualification.
• Management of the Design Team and Project Contractors.
• Maintain Project Schedule and update in line with plan.
• Management of project change control and coordination of activities with the site.
• Follow-up and close out of actions arising from QA and Safety audits.
• Communicate project status to internal and external stakeholders.
• Comply with site GMP & EHS requirements both from a local, global, and regulatory perspective.
• Resolve technical issues in an effective & timely manner to support operations.
• Manage and coordinate external contractors as required from supplier agreements.
• Communicate effectively with client and engineering team.
• Ensure equipment/systems meets the required legal, divisional, and corporate standards.

 Experience & Skills for the role:

• Degree in Engineering or Project Management.
• 5+ years’ experience in Project Management/Engineering. 
• Proven experience in capital project delivery on Medical Device/Pharmaceutical site.

Lead Electrical Project Engineer

A position has arisen with an international bespoke equipment manufacturer based in North-East Cork, with a significant focus on the pharmaceutical industry. Recently acquired by a larger group, the organisation contributes significantly to an annual turnover of €100 million and has a significant footprint especially within the pharmaceutical industry in Ireland and Europe.

The purpose of this position is to manage the delivery of multiple electrical and automation projects and lead other engineers. This is a permanent full-time position. 

Roles & Responsibilities:

• Responsibility for managing the delivery of multiple electrical and automation projects.
• Interface with clients, manage vendors/sub-contractors and ability to work within a multi-disciplined engineering team.
• Generate Cost Estimates with the Sales Department (based on clients URS, P&ID, Equipment list and local and national regulations)
• Management of other electrical engineers within the department.
• Assess client automation requirements and System Architectures to meet specific project needs
• Reading design specifications and technical drawings
• Liaising with others in the Design team
• Technically co-ordinate automation and electrical subcontracts that the Company place
• Specify and procure process instrumentation, equipment and hardware
• Review/Approve HDS, FDS, SDS and Test Packs for automations and electrical projects in accordance with GAMP protocols and project specifications
• Generate design documentation including wiring drawings
• Setup and troubleshoot process equipment and instrumentation
• Organise and Manage the Factory Acceptance Test (FAT) activity
• Attend Hardware and Software FAT’s and act as BCD witness/approver of same
• Provide FAT and Commissioning Support for integrated process systems
• Management of Electrical & Automation Subcontractors.

Educational requirements:

• Engineering degree or equivalent trade qualifications/experience. 

Essential Experience & Role Requirements: 

• 2-5 years experience in a similar position.
• Automation Experience is advantageous but not required.
• Design experience of Biotech, API, food and beverage or aseptic processes gained within an engineering design office or equipment supplier is a distinct advantage.
• Authorised to work in Ireland i.e, hold a valid work permit, or a stamp 4 visa.

Job description

Due to continued growth, Dolmen Engineering is looking to hire an Engineering Sales Coordinator to join our Dublin based Business Development and Sales team. The successful candidate will be welcomed into a highly personable and dynamic engineering-consulting environment. This role will report to the Business Development manager. The Engineering Sales coordinator will be responsible for supporting the team in its Business Development initiatives, assisting with the day-to-day operations of managing a Sales function.

As a Technical Sales Coordinator at Dolmen Engineering your day-to-day role would involve, but would not be limited to the following activities:

• Working with Dolmen’s technical team to develop commercial proposals, including the pricing strategy, for the Irish and European Life Sciences projects.
• Supporting the review, assessment, and response to Request for Proposals (RFPs).
• Optimization and maintenance of Dolmen’s existing CRM infrastructure to ensure system stability, data quality and continuous improvement in our CRM system.
• Optimizing sales efficiency by refining and updating the CRM system to develop integrated pipeline and reporting views.
• Support the Business Development team to forecast and manage the sales funnel by ensuring all customer interactions and opportunity updates are tracked and tasked appropriately.
• Manage the CRM tasks list, ensuring that tasks that support Dolmen’s sales strategy are addressed and closed.
• Support and as appropriate, train the Business Development team in the use of the CRM and other tools.
• Support the development of external presentations and marketing material.

Competencies

To perform the job successfully, an individual should demonstrate the following competencies:

• Drive & discipline – ability to focus and work hard to achieve the right results
• Ability to work in a fast-paced environment and multi-task while paying close attention to detail
• Autonomy and Initiative

Qualifications

• Minimum 3 years’ experience using a CRM software
• Technical writing experience
• An Engineering or technical background is preferred
• Excellent interpersonal and communication skills.
• Ability to work on multiple assignments.

Description

Due to continued growth, Dolmen Engineering currently have a requirement for a Technical Recruiter to join our Contract Services team based in Parkwest Dublin. This role will report to the Contracts Services Manager. The recruiter will be responsible for both internal and external recruitment mandates, sourcing top talent and managing existing accounts, utilizing a variety of search methods focusing on the passive candidate market both internally and externally.

The successful applicant will have a passion for recruitment, an entrepreneurial spirit and enjoys a busy and dynamic environment, with a steady pipeline of positions to recruit. This is a fantastic opportunity to be involved in a start-up style environment, allowing you to grow and develop with the business.   

Roles and Responsibilities

• Understanding internal talent needs within Dolmen Engineering and collaborating with function leads in the recruitment process.
• Understanding Clients recruitment needs and working with hiring managers to define role requirements.
• Identifying and attracting talent into the business from a wide variety of on and off-line sources, e.g., social networks, executive recruitment, developing networking channels, etc.
• Sourcing and screening candidates and submitting to hiring managers.
• Leading and managing the interview process with hiring managers and/or HR including post interview evaluations and providing interview feedback.
• Monitoring recruitment through to negotiation and candidate acceptance.
• Updating the ATS on a daily basis so as to ensure information is kept up to date.
• Support end to end recruitment to ensure timely turnaround times and 1st class Clients and candidate experience.
• Tracking recruitment performance versus KPI’s and identifying areas for improvement.
• Look to develop a pipeline of talent across the business to support future growth and bring a more strategic focus to recruitment.

Education and Experience

• Strong recruitment experience ideally within an engineering or other technical environment.
• Third level qualification in HR, Business, or a technical discipline and at least 2-5 years recruitment experience.
• Strong understanding of the various engineering disciplines within the Life Sciences Industry.
• Enjoys building client relationships
• Target driven

Key Skills

• Excellent written and verbal communication skills.
• Organization and planning.
• Persuasiveness/Influencing.
• Networking.
• Finisher, i.e., can close deals effectively and in a timely manner.

Validation Engineer

·   Ensure all aspects of activity within the Quality Engineering Group adhere to required policies and procedures, including safety and training.

·   Ensure that the plant meets the quality requirements of its customers with respect to Validation and Calibration, ISO 9001:2015 / ISO 13485:2016, In Vitro Diagnostics Directive, Division & Corporate Policies and other external standards.

• Be involved in all Validation Cross Functional Teams (CFT’s) at the site to ensure adherence to required policies and procedures, including safety and training.

• Assist in preparation and execution of validation protocols.
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.

·   Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues.

• Lead validation aspects of Facility, Utility, Equipment qualifications
• Conduct Test Method Validation, Gauge R&R
• Lead software validation and 21CFR Part 11 assessments

·    Assist in the development of the existing Validation Program at AIDD to ensure continued compliance to the necessary regulations.

·   Collate and Report on relevant Validation data/matrices.

·   Ensure prompt attention to the Quality Engineering Manager on areas of non-compliance.

• Ensure all Validation and Calibration documentation meets the requirements of Quality Records Procedures.

·   Develop and rollout ‘Validation Training’ for the site on subjects assigned by the Quality Engineering Manager.

·   Keep abreast of developments in customer requirements to ensure the plant continues to produce quality products under regulatory requirements.

·   Liaise with and seek appropriate advice from other company plants worldwide.

·   Participate as required in project activities to achieve plant goals.

·   Ensure all relevant employees are aware of Division and relevant International Standards and their implementation throughout the plant.

• Participate in identifying and implementing cost reductions, which do not adversely impact product quality.
• Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager.

Dolmen Engineering is currently looking for a Regulatory Affairs Manager for our client site in Longford. The Regulatory Affairs manager will work on the regulatory activities related to both ongoing and planned REACH projects.

• Provide Regulatory input to Design Plan cross functional teams: evaluate proposed changes for regulatory impact.
• Review and approve study protocols and records that will from part of Regulatory submissions.
• Work with the Medical Writing group in coordinating activities related to the preparation and compilation of data and information into a comprehensive package for regulatory submissions, ensuring tasks are completed on time.
• Issue Notifications of Change to Notified Body and / or country affiliates as appropriate.
• Coordinate with manufacturing sites, third party manufacturers and countries to ensure all necessary documentation is provided to facilitate timely completion of Regulatory submissions & acquisition of approvals.
• Real time tracking of submission and approvals: monitor applications under regulatory review and communicate application progress to internal stakeholders.
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities in a timely manner
• Ensure compliance with product post - marketing approval requirements.
• Ensure external communications meet regulations.
• Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation, and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Other duties as assigned, according to the changing needs of the business.

Education & Experience

• Bachelor's degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
• 5 years’ experience in a regulated industry (e.g. medical products) would be an advantage
• Minimum of 3 years’ experience in Regulatory Affairs.
• Experience with EU and other international medical device regulations and submissions.  
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Certification in Regulatory Affairs preferred.

Key Skills

• Ability to work in a matrixed and geographically diverse business environment with people from various disciplines and cultures
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Possess good written and oral communication skills. 
• Strong organisational and follow-up skills, attention to detail, excellent interpersonal skills to deal with multiple business functions and personnel across the organisation, ability to identify obstacles and offer solutions.  

Product Development Engineer

Dolmen Engineering currently have a requirement for a Product development Engineer for our client site in Castlebar Co. Mayo. As a Project Leader in the Product Development department, you will be responsible for management of product focussed projects.

Essential Duties and Responsibilities:

The Product Development Project Lead will have responsibility for management of product specific projects including:

•Coordinating & Managing R&D projects including New Product Introduction (NPI) and Product Transfers into the manufacturing plant.
• Providing regular project updates on project activities, milestones and status.
• Project scoping, costing & budget tracking.
• Managing projects liaising with local and global cross functional teams.
• Writing manufacturing validation protocols & reports for Feasibility trials, Process Evaluations, Registration Stability builds & Value Improvement Processes (VIPs)
• Tracking and ensuring completion of project milestones and compliance to project timelines.
• Managing product, process and supplier changes which have a potential impact on products manufactured in Castlebar using the Design Change Control process.
• Coordinating document generation and review of Product File submissions to regulatory agencies. (FDA, HPRA, MHRA, EU RMS)
• Compliance to cGMP and Corporate Quality procedures.


Qualifications, Key Skills and Experience:

• B.sc in Science (Engineering, Chemistry, Biology).
• Strong relevant Pharmaceutical/Healthcare experience.
• Demonstrating Strong project management and team leadership skills.
• Proven ability to work cross functionally as this role requires interaction with different functions within the plant.
• Analytical thinking using established tools for trouble shooting and investigation management.
• Ability to communicate (written and verbal) in a clear and concise manner.