Pharma Parenterals Fill & Finish

Biologics Drug Product | Sterile Manufacturing | 6-month contract

Our customer is a leading international biopharmaceutical company with a strong manufacturing presence in Switzerland. We are looking for an experienced MSAT professional with hands-on expertise in commercial biologics Drug Product manufacturing and sterile Fill & Finish.

Your responsibilities

• Provide MSAT support for commercial sterile Drug Product manufacturing, including parenteral compounding and filling
• Lead manufacturing deviations and investigations, including root cause analysis, product impact assessment and CAPA definition
• Support Continuous Process Verification (CPV) and process capability/trending activities
• Assess manufacturing and process changes from a technical and product-impact perspective
• Review technical documentation and manufacturing data
• Support process robustness and continuous improvement activities
• Collaborate with cross-functional teams and external manufacturing partners/CMOs

Your profile

• Scientific, pharmaceutical or engineering degree
• At least 5 years of relevant experience in sterile/parenteral Drug Product manufacturing
• Strong hands-on knowledge of compounding and Fill & Finish, ideally involving vials, pre-filled syringes and/or cartridges
• Strong experience with deviation investigations, root cause analysis, CAPAs and change control
• Good understanding of aseptic processing, GMP and global regulatory requirements
• Experience with risk assessment tools such as pFMEA / Ishikawa
• Experience with CPV, process trending and statistical tools such as Minitab or JMP is an advantage
• Fluent English; French is an advantage

You are a pragmatic and solution-oriented MSAT professional who enjoys working close to manufacturing and solving complex technical issues in a highly regulated biologics environment.

Location: Switzerland / Neuchatel – approx. 50% on site
Start: ASAP
Duration: 6 months, with possible extension

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