Senior Aseptic Design Engineer

About

Recrutis is supporting a leading international biopharma client based in the Bern region in the search for a Senior Aseptic Design Engineer. The role owns aseptic design deliverables across three sterile filling lines under upgrade — concept, implementation, commissioning support — within a multi-year sterility assurance programme.

Why this role

• Full technical ownership of aseptic design across 3 sterile filling lines, end-to-end
• Strategic Annex 1 sterility assurance programme on a flagship European biopharma site
• 24-month consulting mission with strong project visibility and direct site leadership access
• Cross-functional environment — OEMs, process engineering, validation, production

Key information

• Location: Canton of Bern, Switzerland — primarily on-site
• Contract: Consulting mission, 24 months
• Start: ASAP, subject to notice period
• Seniority: 7-12 years in pharma / biotech aseptic design
• Languages: English C1 mandatory ; German B2 strongly preferred

Scope

• Lead design and optimisation of aseptic equipment — isolators, RABS, VHP decontamination, point-of-fill filtration
• Author engineering documentation — URS, FS, TS, P&IDs, layouts and design reviews
• Coordinate with OEMs, suppliers and equipment vendors across design, procurement and commissioning
• Participate in FAT, SAT and commissioning, ensuring systems meet design specifications and Annex 1 requirements
• Maintain change control and provide design support through start-up and qualification phases

Required criteria

• Confirmed 7-12 years of hands-on aseptic Fill & Finish design experience in pharma / biotech
• Direct experience with isolators, RABS, VHP and point-of-fill filtration on commercial sites
• Direct experience on an Annex 1 remediation or upgrade programme (not general cGMP exposure)
• English working proficiency (C1)

Strong assets

• URS / FS / TS authorship as primary author
• CQV / QA / Validation cross-functional exposure
• MSAT or sterile Production cross-functional background
• German B2-C1 for direct site interactions

Process

• Confidential recruitment process. Response within 48 hours for applications meeting required criteria. Active mandate, priority review.

Keywords

aseptic design, fill & finish, F&F, sterile manufacturing, isolators, RABS, VHP, point-of-fill filtration, EU GMP Annex 1, sterility assurance, URS FS TS, FAT SAT commissioning, biopharma, pharma, Bern, Switzerland, consulting mission.