About this role
Serve as a global subject matter expert for aseptic equipment and sterile processing, spanning design through lifecycle support. Ensure equipment and practices align with EU GMP Annex 1, sterility assurance, and contamination control requirements while supporting capital projects and operational sites worldwide.
Key Responsibilities
- Provide global subject matter expert leadership for aseptic manufacturing equipment design and lifecycle management
- Ensure EU GMP Annex 1 compliance and align with sterility assurance and contamination control strategies
- Support Contamination Control Strategies (CCS) implementation including minimization of operator interventions and sterilization/decontamination effectiveness
- Lead technical evaluations and technology selection for aseptic filling systems (vial, syringe, cartridge)
- Troubleshoot complex aseptic equipment issues and support startup and qualification
Technical Overview
Leads aseptic manufacturing equipment engineering for pharmaceutical and biologics facilities, covering technology selection, commissioning, qualification, and lifecycle support. Provides technical leadership on contamination control strategies, sterility assurance principles, and troubleshooting for isolators, barrier systems, sterilization systems, and aseptic filling lines including vial/syringe/cartridge fill systems.
Ideal Candidate
The ideal candidate is a Senior Principal Engineer / Senior Technical Expert who has served as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies. They can ensure EU GMP Annex 1 compliance, lead Contamination Control Strategies (CCS), and provide deep technical leadership across design, specification, commissioning, qualification, troubleshooting, and lifecycle support.
Must-Have Skills
Designspecificationand lifecycle management of aseptic equipmentEnsure equipment design and operational practices comply with EU GMP Annex 1: Manufacture of Sterile Medicinal ProductsSupport Contamination Control Strategies (CCS) across sterile manufacturing facilitiesProvide technical input during regulatory inspections and responsesTroubleshoot complex aseptic equipment issues and support startup and qualificationCommissioning and qualification support for aseptic manufacturing equipment
Nice-to-Have Skills
Evaluating emerging technologies
Tools & Platforms
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
Required Skills
aseptic manufacturing equipmentsterile processing technologiesdesigntechnology selectioncommissioningqualificationlifecycle managementlifecycle supportEU GMP Annex 1Manufacture of Sterile Medicinal Productssterility assurance principlescontamination control strategiesContamination Control Strategies (CCS)contamination risk assessmentsregulatory inspectionsisolatorsbarrier systemssterilization systemsaseptic filling linesvial fillingsyringe fillingcartridge fillingtroubleshootingstartup and qualification
Hard Skills
Aseptic manufacturing equipment designSterile processing technologiesTechnology selectionCommissioningQualificationLifecycle supportAseptic filling linesIsolatorsBarrier systemsSterilization systemsSupporting equipmentEU GMP Annex 1 alignmentSterility assurance principlesContamination control strategiesContamination Control Strategies (CCS) implementationSterility assurance principles equipment designMinimization of operator interventionsEffective sterilization and decontamination processesContamination risk assessmentsRegulatory inspections supportResponses related to sterile manufacturing equipmentTroubleshooting complex aseptic equipment issuesEvaluating emerging technologiesSupporting successful startup and qualificationBest-in-class technology adoptionEngineering standards and best practices for sterile manufacturing equipmentTechnology leadershipTechnical evaluations and technology selection for aseptic manufacturing systemsVial fillsyringe fillcartridge fill
Soft Skills
Global subject matter expert leadershipTechnical leadershipLeadership in adoption of best-in-class technology and engineering practicesTroubleshooting leadershipCross-functional alignment and communication in a matrix organizationCross-functional collaborationStakeholder communicationLeadership in startup and qualification support
Keywords for Your Resume
Senior Principal EngineerSenior Technical ExpertAseptic EquipmentSterile Processingglobal subject matter expertsubject matter expertaseptic manufacturing equipmentsterile processing technologiesdesigntechnology selectioncommissioningqualificationlifecycle managementlifecycle supportEU GMP Annex 1EU GMP Annex 1: Manufacture of Sterile Medicinal Productssterility assurance principlescontamination control strategiesContamination Control StrategiesCCScontamination risk assessmentsregulatory inspectionssterile manufacturing equipmentisolatorsbarrier systemssterilization systemsaseptic filling linesvialsyringecartridge fillingtroubleshootingContamination Control Strategies (CCS)
Deal Breakers
Must be able to align equipment design and operational practices with EU GMP Annex 1: Manufacture of Sterile Medicinal Products, Must have demonstrated experience with Contamination Control Strategies (CCS) and sterility assurance principles for sterile manufacturing equipment
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