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Process Mechanical Engineer - Fill Finish Equipment, Cork
Client:
PM Group
Location:
Cork, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
6378d47403b5
Job Views:
2
Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
Overview: We are looking for Intermediate and Senior Mechanical Engineers with experience in Fill Finish equipment to join our expanding Mechanical Engineering team. Our strong portfolio of upcoming pharmaceutical projects requires experienced professionals to help us deliver projects to our tier 1 clients in 2024. As a Mechanical Engineer, you will work as part of the Process Mechanical Engineering Team, owning Filling Line equipment packages through the complete lifecycle from design development through to integration on site. You will have the opportunity to work alongside our in-house Fill Finish Subject Matter Experts (SME) and develop your engineering skills. This role also provides excellent long-term career development, including the opportunity to progress along the PM Group technical career development path with the potential to join our in-house SME development program.
Responsibilities:
As a Process Mechanical Engineer – Fill Finish Equipment within PM Group you will be responsible for:
1. Collaboration with in-house Fill Finish SME network to ensure design adherence to latest industry standards and best practice.
2. Ownership of Fill Finish equipment modules and packages through complete lifecycle.
3. Specification of Fill Finish equipment through design and procurement phases.
4. Generation of Data Sheets, Material Requisitions & Enquiry Packages for procurement of Fill Finish equipment.
5. Generation of Technical Bid Tab.
6. Evaluation of vendors in compliance with Client specifications.
7. Developing Technical Specifications in compliance with Client requirements.
8. URS development for Client may be required on some projects.
9. Ownership of each package through Kick-off meetings, Design Reviews, FATs, etc.
10. Project manage Suppliers to ensure packages are designed, manufactured and tested as per project requirements.
11. Interfacing with clients, vendors, client project management and other disciplines ensuring the highest level of service is provided.
12. Technical review of Vendor design to ensure interface with facility design team and adherence to client requirements and specifications.
13. Mechanical optimization/site support.
Qualifications:
To be considered for this role, you will have:
1. Minimum of 5 years working directly on Fill Finish equipment through design phase. This may be through time at an equipment supplier, design consultancy or in a manufacturing environment.
2. Degree in Mechanical Engineering (Engineers with a primary degree in Chemical/Process Engineering and relevant process experience may also be considered).
3. Significant design experience in the Pharmaceutical and Biopharmaceutical sectors.
4. Self-starter with confidence in coordinating the efforts of others.
5. Good communication skills (ability to lead Technical reviews with Clients and Suppliers).
6. Openness to travel to where equipment is being manufactured.
Suitable Candidates shall have knowledge of some or all of the following areas:
1. Deep knowledge of various filling and closing equipment.
2. RABs & Isolators.
3. Lyophilisers.
4. Inspection equipment.
5. Packaging equipment.
6. Principles of facility layout such as: Area classifications associated with the required process steps, Layout adjacencies, Segregation approaches.
7. Aspects related to unit operations and technologies such as: Small and Large volume parenterals, Formulation, Freeze/Thawing, Filling and closing, Lyophilisation, Sterilisation and sanitisation, Filling path, Inspection, Single use technology, Component preparation and support areas, Integrity testing, CIP/SIP, Clean Utility generation and distribution systems, Waste systems.
8. Aspects related to facility operations such as: Operating philosophies, Lean/Sigma Concepts, Machine Efficiency (OEE), Contamination control, GMP Regulatory framework, particularly Annex 1 and FDA.
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