Fill Finish Subject Matter Expert (SME) > Antwerpen > Joboolo BE :
Société : PM Group Lieu : Antwerpen Flanders Site source : Talent BE
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 SubjectMatterExperts in the companyTo participate and/or chair technical design reviews as appropriateTo actively support and participate in PM Groups R&D Team (the 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 includePrinciples of facility layout such as:
Area classifications associated with the required process stepsLayout adjacenciesSegregation approachesAspects related to unit operations and technologies such as:
Small and Large volume parenteralsFormulationFreeze/ThawingFilling and closingLyophilisation Sterilisation and sanitisationFilling pathInspectionSingle use technologyComponent preparation and support areasIntegrity testingCIP/SIPClean Utility generation and distribution systemsWaste systemsAspects related to equipment such as:
Deep knowledge of various filling and closing equipmentRABs & IsolatorsLyophilisersInspection equipment Packaging equipmentAspects related to facility operations such as:
Operating philosophiesLean/Sigma ConceptsMachine Efficiency (OEE)Contamination controlGMP Regulatory framework, particularly Annex 1 and FDAAspects related to project delivery such as:
Basis of designBasis of safetySimulation toolsCapacity calculationsTech TransferCommissioning and Qualification Qualifications Bachelor’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. PM Group AntwerpenFlanders
