Fill Finish Subject Matter Expert
il y a 2 semaines
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Fill Finish Subject Matter Expert (SME), AntwerpenClient: PM Group
Location: Antwerpen
Job Category: Other
EU work permit required: Yes
Job Reference: a2a1ace4c231
Job Views: 5
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:Overview: The role is to work as a Subject Matter Expert providing technical leadership on Fill Finish. As a member of the global SME Group, the person employed can be located in one of the PM Group offices in Ireland, UK, Belgium, The Netherlands, or Poland. We work a hybrid work model while the role will require travel to project meetings/workshops as required.
Who we are: PM Group is an employee-owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech, and mission-critical sectors. From our network of offices in Europe, Asia, and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered around our people, our clients, and trade partners.
Responsibilities:- To be a technology leader in nominated area(s) which includes:
- Being current in technical and subject knowledge
- Being aware of upcoming technology changes, developments, innovations
- Writing papers, presenting at industry conferences
- Being involved with industry bodies such as the ISPE, ICHEME, BioPhorum
- Promoting knowledge exchange within the company using appropriate forums, COPs, and teams
- To perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept, and Basic Design phases).
- To technically assist project teams as required.
- To undertake Peer Reviews of work performed by other companies.
- To engage with a global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the company.
- To participate and/or chair technical design reviews as appropriate.
- To actively support and participate in PM Groups R&D Team (the TechTeam) and associated development and innovation activities.
- To support BD as required, including client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.
- Travel to Project meetings/workshops as required.
- Other special projects as assigned.
- Principles of facility layout such as:
- Area classifications associated with the required process steps
- Layout adjacencies
- Segregation approaches
- 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
- Aspects related to equipment such as:
- Deep knowledge of various filling and closing equipment
- RABs & Isolators
- Lyophilisers
- Inspection equipment
- Packaging equipment
- 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
- Aspects related to project delivery such as:
- Basis of design
- Basis of safety
- Simulation tools
- Capacity calculations
- Tech Transfer
- Commissioning and Qualification
- Bachelor's degree; Masters preferred
- 15 years+ of appropriate experience in design and/or operations and/or process development
- A history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and direction
- Excellent knowledge relating to area of speciality
- A good understanding of the principles of facility layout and design as appropriate
- Good appreciation of appropriate Regulatory framework
- Good presentation skills and be comfortable client interfacing, facilitating workshops and technically assisting project teams.
- Have the ability to distil down problems to their essence, demonstrate problem solving ability, and have an ability to innovate.
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