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Fill Finish Subject Matter Expert

3 months ago

Burlington, United States PM Group Full time

:
The Fill Finish SME position is an exciting opportunity to join PM Group’s quickly growing US team located out of any of our US East Coast based offices. Together we will all be sharing knowledge, learning, growing, and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. Our offices are executing cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities - from feasibility through to qualification - for both local and international clients. With our clients and partners, we will deliver projects that improve the everyday lives of people across the globe.

We are looking for a Fill Finish SME who enjoys client interaction as well as the technical aspects of the work we deliver to our clients. The ability to inspire confidence from first contact through proposal preparation and project execution is important as a client facing SME. As a Subject Matter Expert you will be providing technical leadership on aseptic fill finish projects group wide.

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, biotech, medical technology 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 on our people, our clients and trade partners.
:

- Act as a technology leader in the following areas:

- Aseptic Fill Finish
- Aware of upcoming technology changes, developments and innovations
- Write papers, and present at industry conferences
- Involved with industry bodies such as the ISPE, Parenteral Drug Administration (PDA), and AIChE
- Promote knowledge exchange within the company using appropriate forums, COPs and clusters
- Support BD as required; this may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials
- Prioritize fill finish prospects in consultation with BD, operations and sector leaders
- Attend bid/no bid discussions and proposal risk reviews
- Participate in client interviews and presentations
- Liaison with global key accounts as appropriate
- Collaborate with the PM Group USA senior leadership, the sector heads & operations teams to develop distinctive value propositions that enhance our clients’ competitive position
- Leverage corporate networks to identify existing capabilities that respond to client requirements and objectives as well as create a distinct competitive advantage
- Engage with an existing global network of Subject Matter Experts and assist in the training and mentoring of the next generation of PM Group Subject Matter Experts
- Represent PM Group at networking events and conferences
- Present and interface with clients and facilitate workshops
- Act as an SME in early project phases (i.e. site master planning, feasibility, concept and basic design phases)
- Once a project is acquired deploy process SME knowledge and expertise to help develop solutions for client’s business and project needs
- Produce and/or check early phase project deliverables appropriate to the discipline speciality including scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, mass balances, bioprocess simulation models, process flow diagrams, and P&ID’s and layout philosophies
- Technically assist project teams, particularly in the early project phases, with site master planning, feasibility and concept studies and basic design
- Break problems down to their essence, demonstrate problem solving skills and innovate
- Travel to Project meetings / workshops as required
- Technically assist project teams as required
- Participate in Peer Reviews of work performed by others and other companies
- Perform, when appropriate, SME reviews of client sites
- Participate and/or chair technical design reviews as appropriate
- Actively support and participate in internal development and innovation activities
- Other special projects as assigned
:

- 15+ years of appropriate experience in design and/or operations and/or process development
- A history of industry engagement with institutions (such as the ISPE) and an awareness of key industry technology initiatives
- Superior proven knowledge of vial filling, syringe filling, lyophilization and other fill finish technologies
- Familiar with equipment options available and the selection criteria as to when such options should be chosen
- Demonstrated understanding of the appropriate principles of facility layout to accommodate an aseptic fill finish facility, and how to achieve the operation with the HVAC grades associated with the required process steps
- A good understanding of isolators and RABs and the associated decontamination systems
- Good presentation skills and comfortable interfacing with clients, facilitating workshops and technically assisting project teams
- The ability to na