Bulk bio subject matter expert (sme)
Solliciteren
Plaats
Amsterdam1000
Noord-Holland
Nederland
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2025-11-06Online tot
2026-01-05EUR 15.00 HOUR
Bulk bio subject matter expert (sme)
- PM Group
- Noord-Holland 1000 Amsterdam
- 4 weken geleden
Overview The Role We 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 are PM 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. 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, Bio Phorum
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). 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 reports
To 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 company
To participate and/or chair technical design reviews as appropriate
To actively support and participate in the PM Group’s R&D Team (Tech Team) 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 required
Other special projects as assigned Specific Knowledge Areas to be covered by the Role include
Upstream 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 steps
Layout adjacencies
Segregation approaches
Aspects related to technologies such as:
Process closure technologies and approaches
Connected and continuous processing
Stainless steel and single-use systems
Bulk bio automation concepts
CIP/SIP
Clean utility generation and distribution
Waste systems
Aspects related to facility operations such as:
Operating philosophies
GMP Regulatory framework
Aspects related to project delivery such as:
Basis of design
Basis of safety
Simulation tools
Tech Transfer
Commissioning and Qualification
Good 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, Vaccines Qualifications
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. 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.
Who we are PM 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. 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, Bio Phorum
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). 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 reports
To 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 company
To participate and/or chair technical design reviews as appropriate
To actively support and participate in the PM Group’s R&D Team (Tech Team) 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 required
Other special projects as assigned Specific Knowledge Areas to be covered by the Role include
Upstream 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 steps
Layout adjacencies
Segregation approaches
Aspects related to technologies such as:
Process closure technologies and approaches
Connected and continuous processing
Stainless steel and single-use systems
Bulk bio automation concepts
CIP/SIP
Clean utility generation and distribution
Waste systems
Aspects related to facility operations such as:
Operating philosophies
GMP Regulatory framework
Aspects related to project delivery such as:
Basis of design
Basis of safety
Simulation tools
Tech Transfer
Commissioning and Qualification
Good 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, Vaccines Qualifications
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. 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.
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