Job description

Due to continued growth, Dolmen Engineering is looking to hire a Bid Manager 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 Market Director. The Bid Manager 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 Bid Manager at Dolmen Engineering your day-to-day role would involve, but would not be limited to the following activities:

• Actively participating and leading sections of pipeline tracking in coordination with other colleagues
• Working with Dolmen’s technical team to develop commercial proposals, including the pricing strategy, for the Irish and European Life Sciences projects.
• Leading and assisting the drafting and composition of bids, proposals, presentations, and concept notes;
• Supporting the review, assessment, and response to Request for Proposals (RFPs).
• Administration of internal tools for managing tender pipeline.
• 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 Sales tasks list, ensuring that tasks that support Dolmen’s sales strategy are addressed and closed.
• Managing and/or assist in the management of handover of projects to the Project Delivery team on contract award.

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

• Excellent interpersonal and communication skills
• Ability to work on multiple assignments

Qualifications

• Minimum 4 years’ experience in an engineering or technical background
• Technical writing experience
• Sales experience is preferred

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. 

Process Engineering Department 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.

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.

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 Senior Project Manager role reports to the Head of Performance & Delivery. A Senior PM will manage key client projects and will oversee all aspects of these projects. They will work directly with clients to ensure deliverables are aligned for scope and budget. They will coordinate with and lead other engineers and project team members to ensure the deliverables of all projects in their portfolio are compatible.

Duties:

Manage and lead large capital projects from Dolmen Engineering offices or from Client sites.
Manage and mentor project team members.
Ensure all company procedures are followed for each stage of project execution
Ensure that all projects are delivered on-time, within scope and within budget.
Ensure and track resource availability across their project portfolio.
Measure project performance using appropriate tools and techniques.
Report and escalate issues to management as needed.
Manage the relationship with the client and all stakeholders.
Attend conferences and training as required to maintain proficiency.
Overall risk management to identify themes.
Facilitate change control process.
Track deliverables and benefit realisation.

Requirements:

Level 8 degree in Engineering or Science discipline or equivalent work experience.
Proven working experience in PM in the Pharma/BioPharma or Medical Device Industries.
10+ years in managing large capital projects.
Strong working knowledge of Microsoft Office suit.
Project Management Professional (PMP) / PRINCE II certification is an advantage.
Developing and Tracking Budgets.
Experience in implementing process improvements using standard LEAN methodologies would be advantageous.

Key Skills

Excellent written and verbal communication.
Financial acumen.
Adept at project and change management.
High level of organisation skills.
Great leadership skills.
Ability to perform under pressure.
Pragmatic
Stakeholder Management

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 Validation Engineer to join our expanding team. The Validation Engineer will be responsible for providing validation leadership on technical projects in various manufacturing facilities. Experience in providing pragmatic solutions to allow for on time project delivery and full integration with the clients Quality Systems is essential. The position will be a mixture of site and office based, dependant on the project.

Responsibilities:

• Provide Validation input into engineering projects in accordance with GMP and SOP’s. This will require supporting the Project Engineers or Project manager to ensure the completion of key milestones and the monitoring of documented evidence which verifies that such milestones have been met.

• Act as the PMO contact person and coordinator for equipment, process and computer validation/test activities.

• Develop Master Validation Plans

• Ensure best validation and test practices are employed across the company to maximize effectiveness and minimize non-value-adding work.

• Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.

• Contribute to the development of FAT/SAT protocols

• Contribute to the development of design documents (FDS/SDS/HDS)

• Participate in pFMEAs/RSKs

• Responsible for the introduction of several pieces of equipment across several facilities accommodating both the design and qualification of equipment

• Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.

• Execute Validation Protocols, root cause deviations and generate validation reports.

• Ensure all results and data are correct and follow-up on any gaps or discrepancies.

• Provide guidance and direction in the preparation and execution of validation activities

Requirements:

• Third level degree in science or engineering

• A minimum of 3 years’ experience in a validation role in the Life Science industry

• Experience in any or all of the following:

• Clear understanding of applicable regulations for the pharma, BioPharma or Medical Device Industries

• Commissioning, Qualification & Validation of new systems and equipment

• Thermal mapping of controlled temperature units

• Sterilisation validation (Example steam, VHP)

• Sterile manufacturing

• Cleaning validation

• Process Validation in Pharma, BioPharma or Medical Device Industries

• Facility/ Utility qualification

Key Skills:

• Strong documentation skills – you will be managing and documenting the validation process as applicable. The documentation produced must comply with both client SOPs and externals regulations.

• Attention to detail – it is vital that validation engineers pay attention to every test result and measurement, noticing when something isn’t quite right.

• Analytical thinking – as well as identifying when there is an issue, part of the role can be to suggest why there might be an issue and potential fixes.

• Enthusiasm for working in a team – validation of equipment systems is a team activity, and you will need good verbal and listening skills to share information amongst the team members

• Good written and oral communication skills – documentation writing is an essential requirement, along with communication with the cliente.

• Preference for a structured approach to working – your work will impact others in the overall Validation team as there will be many documents that require sharing and signing with multiple team members.

• Project management – Ensure the assigned projects are delivered on schedule and within budget.

Project Engineer

We are looking for a Project Engineer to successfully support the projects of a leading Pharmaceutical Company based in Sligo.

Duties:

• Small Projects coordination
• Managing of Contractors
• Completing EHS induction and Contractor permits
• Uploading safety cert for all contractors
• Review of risk assessments and method statement to align with above tasks
• Interacting daily with the clients to interpret their needs and requirements and representing them in the field
• Review all technical aspects of projects
• Monitor compliance to all aspects of H&S, Quality and Engineering Standards 
• Manage schedules, and budgets for projects
• Complete drawing updates and document updates to align with project and site requirements
• Complete validation protocols to align with project requirements
• Report weekly to management on updates in relation to projects

Requirements:

• Degree qualification in a relevant engineering, science or technical discipline
• 2-3 years’ experience in Biopharmaceutical Industry
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
• Knowledge of cGMP and regulatory requirements relating to the Healthcare industry is required
• Proficiency in AutoCAD and Microsof Office

The Senior Validation Consultant will provide Validation input into engineering projects in accordance with GMP and SOP’s. The role will be based in county Mayo.

Responsibilities
·    Ensure best validation and test practices are employed across the company to maximize effectiveness and minimize non-value-adding work.
·    Execute What-if Analyses, reviewing previous Risk Assessments, pFMEAs, Handling of Change Controls, Discrepancies and Deviations related to manufacturing and packaging activities in order to improve the operability of all packaging lines.
·    Support upgrades applications by completion of change control actions, risk assessments, integration protocols, test scripts and summary reports.
·    Complete Process and Equipment Validation including protocol development, execution and report generation.
·    Perform FMEA’s and What if analysis.
·    Implement process control and ensuring process capability is maintained and identifying opportunities for process improvements.
·    Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to packaging equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
·    Ensure all results and data are correct and follow-up on any gaps or discrepancies.
·    Carry out product impact assessments to support change control.

Requirements
·    Third level degree in science or engineering.
·    A minimum of 10 years’ experience in a validation role in the Life Science industry.
·    Clear understanding of applicable regulations for the pharma, BioPharma or Medical Device Industries.
·     Review of existing systems and equipment with the intention to optimize output.
·    Process Validation in Pharma, BioPharma or Medical Device Industries.
·    Experience with Risk Assessments and Failure mode and Effects Analysis.

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.

Due to our continued growth and expansion, we are seeking to hire an Office support. The position will be based in the company’s Head Office in Castlebar and will reporting to the Finance Lead. This is a permanent position.

Duties:

• Handling email and phone inquiries.
• Taking messages and redirecting calls as required.
• Assisting colleagues whenever possible.
• Managing the travel plans, appointments, and agendas of senior management.
• Taking inventory and replacing office supplies when necessary.

• Overseeing the maintenance of office facilities, and equipment

• Submitting reports and preparing presentations and general research.
• General understanding of finance system (QuickBooks) inputs - expenses, project creation, customers, sales, taxes

• Creating and updating databases for various forms of data, including personnel and financial information.
• Performs other related duties as assigned.

Required skills and qualifications

• Third level qualification in HR or Business Management discipline.
• High level of proficiency in Microsoft office suites – Word, excel, SharePoint.
• Excellent written and verbal communication skills.
• Strong organisation and planning skills.
• Ability to multitask.
• Energetic and willing to learn / take on new challenges.
• Flexible and adaptable.

Desirable

• Previous experience on an admin or co-ordinator role within a Business Function
• SharePoint experience. 

Skills:

Microsoft, Microsoft Word, Microsoft Excel.

Project Manager

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

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 meet 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.