Bulk Bio Subject Matter Expert (SME)

OverviewThe RoleWe have an exciting opportunity for a Bulk Bio SME to join our team.The role is to work as a Subject Matter Expert providing technical leadership on Bulk Bio. 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 ArePM Group is an employee owned, international project delivery firm with a team of 3,800+ 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 organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.ResponsibilitiesTo be a technology leader in nominated area(s) which includes:Being current in technical and subject knowledgeBeing aware of upcoming technology changes, developments, innovationsWriting papers, presenting at industry conferencesBeing involved with industry bodies such as the ISPE, ICHEME, BioPhorumPromoting knowledge exchange within the company using appropriate forums, COPs, and teamsTo perform as an SME for the early project phases (i.e. ideally Site Master Planning, Feasibility, Concept and Basic Design phases). Typically this will include production and/or checking of early phase project deliverables appropriate to discipline speciality. This will include scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, P&ID’s and layout philosophies, early phase project reportsTo technically assist project teams as required.To undertake Peer Reviews of work performed by other companies.To perform in appropriate SMEs reviews of client sites.To engage with global network of SMEs and other staff and assist in the training and mentoring of the next generation of Subject Matter Experts in the companyTo participate and/or chair technical design reviews as appropriateTo actively support and participate in the PM Group’s R&D Team (TechTeam) and associated development and innovation activities.To support BD as required. This may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials.Travel to Project meetings /workshops as requiredOther special projects as assigned Specific Knowledge Areas to be covered by the Role includeUpstream and downstream unit operations and support functions, as well as familiarity of equipment options available and the selection criteria as to when such options should be chosen.Principles of facility layout such as:Area classifications associated with the required process stepsLayout adjacenciesSegregation approachesAspects related to technologies such as:Process closure technologies and approachesConnected and continuous processingStainless steel and single-use systemsBulk bio automation conceptsCIP/SIPClean utility generation and distributionWaste systemsAspects related to facility operations such as:Operating philosophiesGMP Regulatory frameworkAspects related to project delivery such as:Basis of designBasis of safetySimulation toolsTech TransferCommissioning and QualificationGood experience of various modalities and expression systems which may include: Mammalian cells, microbial systems, plant cells, insect cells, blood fractionation, CGT, RNA, Oligonucleotides, Peptides, ADCs, VaccinesQualificationsBachelor’s degree; Masters preferred 15 years+ of appropriate experience in design and/or operations and/or process developmentA history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and directionExcellent knowledge relating to area of specialityA good understanding of the principles of facility layout and design as appropriateGood 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.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 2024 Environmental, Social and Governance Report.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.