Manufacturing Asset Specialist

In this role you support the OneSource team on a customer site to ensure accurate calibration, maintenance, and asset validation. You will collaborate with calibration and maintenance engineers to close documentation gaps and release assets after successful work. Your focus on regulatory compliance and data integrity sustains GMP-like standards while contributing to cross-functional investigations. This is a hands-on role at a global company solving critical customer needs, with growth opportunities in a hybrid environment.

• Review and approve documents for calibration, maintenance, and repair work; release assets after completion
• Collaborate with Calibration & Maintenance Engineers to close GDocP gaps
• Process changes, deviations, and CAPA related to calibration and maintenance
• Participate in cross-functional investigations and teams
• Manage asset records in CCMS/CMMS; validate and release entries in CCMS/CMMS systems
• Review and approve administrative releases of calibration/maintenance entries in CCMS/CMMS

• 3–5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Operator process specialist experience
• Bachelor in Life Sciences or Quality/Compliance (or equivalent) preferred
• Knowledge of cGMP and validation regulations; GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred
• Strong written and verbal English; German is strongly preferred
• Customer service mindset; attention to detail; ability to work independently or in a team; adherence to SOPs and regulatory guidelines (FDA, EU, SwissMedic)

• attention to detail
• strong communication
• customer service mindset
• cGMP knowledge
• GDocP familiarity
• GMP/GLP knowledge