PM Group
Fill Finish Subject Matter Expert ( SME )
PM Group, Conshohocken, Pennsylvania, us, 19429
:The Fill Finish SME position is an exciting opportunity to join PM Groups 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 Groups 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 FinishCurrent in technical and subject knowledgeAware of upcoming technology changes, developments and innovationsWrite papers, and present at industry conferencesInvolved with industry bodies such as the ISPE, Parenteral Drug Administration (PDA), and AIChEPromote 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 materialsPrioritize fill finish prospects in consultation with BD, operations and sector leadersAttend bid/no bid discussions and proposal risk reviewsParticipate in client interviews and presentationsLiaison with global key accounts as appropriateCollaborate with the PM Group USA senior leadership, the sector heads & operations teams to develop distinctive value propositions that enhance our clients competitive positionLeverage corporate networks to identify existing capabilities that respond to client requirements and objectives as well as create a distinct competitive advantageEngage 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 ExpertsRepresent PM Group at networking events and conferencesPresent and interface with clients and facilitate workshopsAct 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 clients business and project needsProduce 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&IDs and layout philosophiesTechnically assist project teams, particularly in the early project phases, with site master planning, feasibility and concept studies and basic designBreak problems down to their essence, demonstrate problem solving skills and innovateTravel to Project meetings / workshops as requiredTechnically assist project teams as requiredParticipate in Peer Reviews of work performed by others and other companiesPerform, when appropriate, SME reviews of client sitesParticipate and/or chair technical design reviews as appropriateActively support and participate in internal development and innovation activitiesOther special projects as assigned:
15+ years of appropriate experience in design and/or operations and/or process developmentA history of industry engagement with institutions (such as the ISPE) and an awareness of key industry technology initiativesSuperior proven knowledge of vial filling, syringe filling, lyophilization and other fill finish technologiesFamiliar with equipment options available and the selection criteria as to when such options should be chosenDemonstrated 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 stepsA good understanding of isolators and RABs and the associated decontamination systemsProven knowledge of appropriate Regulatory requirements and their application to aseptic fill finish systemsGood presentation skills and comfortable interfacing with clients, facilitating workshops and technically assisting project teamsThe ability to narrow problems down to their essence; demonstrated problem solving abilitiesThe ability to inspire confidence in staff and clients from first contact through proposal preparation and project executionAbility to innovateSelf-driven, result-oriented, positive outlook and a clear focus on businessComfortable representing PM Group and dealing with multi-national clientsAbility to work flexibly and travel as necessary for the business and client needsStrong internal and external relationship building skillsAbility to work as a member of a team as well as independentlyExperience working in local and international business with the added complexity of new markets, extended communications and cultural factorsAll of your information is confidential according to EEO guidelines.Why PM Group?As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our
Corporate Responsibility and Heath, Safety & Well-being Report 2022.Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.RECRUITMENT AGENCIES NEED NOT APPLY#LI-LB1#LI-hybrid
Aseptic Fill FinishCurrent in technical and subject knowledgeAware of upcoming technology changes, developments and innovationsWrite papers, and present at industry conferencesInvolved with industry bodies such as the ISPE, Parenteral Drug Administration (PDA), and AIChEPromote 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 materialsPrioritize fill finish prospects in consultation with BD, operations and sector leadersAttend bid/no bid discussions and proposal risk reviewsParticipate in client interviews and presentationsLiaison with global key accounts as appropriateCollaborate with the PM Group USA senior leadership, the sector heads & operations teams to develop distinctive value propositions that enhance our clients competitive positionLeverage corporate networks to identify existing capabilities that respond to client requirements and objectives as well as create a distinct competitive advantageEngage 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 ExpertsRepresent PM Group at networking events and conferencesPresent and interface with clients and facilitate workshopsAct 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 clients business and project needsProduce 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&IDs and layout philosophiesTechnically assist project teams, particularly in the early project phases, with site master planning, feasibility and concept studies and basic designBreak problems down to their essence, demonstrate problem solving skills and innovateTravel to Project meetings / workshops as requiredTechnically assist project teams as requiredParticipate in Peer Reviews of work performed by others and other companiesPerform, when appropriate, SME reviews of client sitesParticipate and/or chair technical design reviews as appropriateActively support and participate in internal development and innovation activitiesOther special projects as assigned:
15+ years of appropriate experience in design and/or operations and/or process developmentA history of industry engagement with institutions (such as the ISPE) and an awareness of key industry technology initiativesSuperior proven knowledge of vial filling, syringe filling, lyophilization and other fill finish technologiesFamiliar with equipment options available and the selection criteria as to when such options should be chosenDemonstrated 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 stepsA good understanding of isolators and RABs and the associated decontamination systemsProven knowledge of appropriate Regulatory requirements and their application to aseptic fill finish systemsGood presentation skills and comfortable interfacing with clients, facilitating workshops and technically assisting project teamsThe ability to narrow problems down to their essence; demonstrated problem solving abilitiesThe ability to inspire confidence in staff and clients from first contact through proposal preparation and project executionAbility to innovateSelf-driven, result-oriented, positive outlook and a clear focus on businessComfortable representing PM Group and dealing with multi-national clientsAbility to work flexibly and travel as necessary for the business and client needsStrong internal and external relationship building skillsAbility to work as a member of a team as well as independentlyExperience working in local and international business with the added complexity of new markets, extended communications and cultural factorsAll of your information is confidential according to EEO guidelines.Why PM Group?As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our
Corporate Responsibility and Heath, Safety & Well-being Report 2022.Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.RECRUITMENT AGENCIES NEED NOT APPLY#LI-LB1#LI-hybrid