(0) Documentation Specialist - II - B2 (03088)

Precision Meets Impact – Shape Documentation Excellence in Clinical Biomanufacturing!

? 01.07.2026 to 30.06.2027 

? Lucerne

? Temporary Assignment

About Our Client

Our client is an internationally active contract development and manufacturing organization (CDMO) specializing in the clinical production of biological drug substances. Known for its rigorous quality standards, innovative approach, and close collaboration between manufacturing, tech transfer, and quality assurance, this company offers a dynamic and highly professional working environment for the GMP Documentation Specialist (m/f/d).

Your Responsibilities

• Operational review of executed batch records for clinical biologics manufacturing, covering Upstream Processing (USP), Downstream Processing (DSP), Weighing & Dispense (W&D), and solution/media preparation
• Ensuring compliance with ALCOA+, GDP, and GMP standards across both paper-based and Electronic Batch Records (EBR)
• Identifying and coordinating the resolution of documentation gaps, errors, and inconsistencies in close collaboration with shop floor teams
• Supporting the creation, revision, and periodic review of batch record templates, SOPs, work instructions, and forms
• Reviewing executed PI sheets in COMET (SAP) to verify material tracking compliance and detect BOM inconsistencies
• Providing input and supporting documentation for deviation investigations and correction activities
• Managing GMP-compliant archiving, version control, and issuance of manufacturing documents

Your Profile

• Bachelor's degree or equivalent experience in life sciences, biotechnology, engineering, or a related field
• Proven experience in a GMP-regulated manufacturing environment, preferably in biologics
• Solid understanding of GDP principles and hands-on experience with batch record review and manufacturing documentation
• Familiarity with paper-based and/or Electronic Batch Records (EBR); experience with MES systems (e.g. PAS-X, Syncade) is an advantage
• Experience with USP/DSP operations and W&D or solution preparation documentation is desirable
• Strong attention to detail, structured working style, and ability to collaborate cross-functionally
• Excellent German and English language skills (written and spoken)

Your Benefits with nemensis ag

• nemensis AG is your specialized recruitment partner in the fields of Life-Science, based in Basel
• Comprehensive guidance and support throughout the entire application process by our experienced consultants
• Access to a broad client network and exciting opportunities in Northwest Switzerland
• Fast and straightforward onboarding through individual coaching and personalized advice

Ready to take on responsibility as a GMP Documentation Specialist (m/f/d) in Lucerne and bring your expertise to a highly specialized environment? At jobboxx ag, we have already connected thousands of candidates with their dream jobs and helped them grow or re-enter the job market. What can we do for you and your career today? Get in touch with us!

? Ali Biltekin, Country Manager, E-Mail schreiben

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