Packaging Specialist Pharma
AXEPTA SAFor one of our international pharmaceutical clients based in the Vaud area, we are currently seeking a
Senior Packaging Engineer for Commercial Operations
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This position reports to the Director of Commercial Packaging Operations and supports commercial packaging activities for marketed Drug Products. The role involves close collaboration with Commercial QA, Supply Chain, Pharmaceutical Development, and external CMOs to ensure compliance, operational excellence, and timely product supply.
Packaging Specialist Pharma
Key Responsibilities
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Provide day-to-day oversight of commercial packaging activities performed at CMOs, ensuring timely delivery of packaging documentation for commercial Drug Products.
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Coordinate and support resolution of packaging deviations and troubleshooting activities at CMOs in collaboration with internal QA and Supply Chain teams.
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Act as Owner and/or Technical Packaging Expert for Change Controls and Deviations within the company’s electronic Quality Management System (eQMS).
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Review and approve packaging-related documentation, including:
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Risk Assessments
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Validation Master Plans and validation reports
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Master Packaging Records
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Drug Product monographs
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Annual Product Quality Reviews (APQRs)
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Continued Process Verification (CPV) documentation related to packaging
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Lead packaging validation programs for small molecule products (Oral Solid Dosage Forms) for product launch, packaging transfer, and optimization projects.
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Participate in CMO audits as a Packaging Subject Matter Expert (SME).
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Ensure all activities comply with company policies, GMP requirements, applicable regulations, and safety standards.
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Contribute to a strong culture of integrity, compliance, and continuous improvement.
Profile & Requirements
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Bachelor’s degree in Packaging Engineering, Pharmaceutical Sciences, or equivalent professional experience.
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Proven experience in the pharmaceutical industry, ideally within packaging operations at a manufacturing site.
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Strong knowledge of packaging validation regulations and cGMP requirements for Drug Products.
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Experience with Oral Solid Dosage Forms (e.g., tablets) required; experience with Semi-Solid Dosage Forms (e.g., creams) is an advantage.
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Experience working with CMOs and external contractors in an international environment.
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Ability to draft and review technical packaging documentation and analyze data using statistical tools.
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Strong communication skills, both written and verbal, with structured and clear reporting.
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Fluent in English (corporate language); French is an asset.
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Willingness to travel up to approximately 10%.
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Results-oriented, proactive, and comfortable working cross-functionally.
QUAI DU SEUJET 12 1201 Genève
