Validation & Maintenance Specialist (m/f/d) 100%
BÜHLMANN Laboratories AG
Schönenbuch
Key information
- Publication date:29 July 2025
- Workload:100%
- Contract type:Permanent position
- Place of work:Schönenbuch
Job summary
Join BÜHLMANN Laboratories AG, a leader in diagnostics! Be part of a supportive team with great benefits.
Tasks
- Plan and document device qualifications (IQ/OQ/PQ).
- Conduct risk analyses and maintain qualified status of equipment.
- Collaborate with production on technical improvements and data care.
Skills
- Bachelor's in Engineering or Life Sciences; 3 years experience required.
- Strong knowledge of GMP, GAMP, and data integrity standards.
- Excellent ERP skills and technical writing experience preferred.
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- Planning, execution, and documentation of equipment qualifications (IQ/OQ/PQ)
- Planning, execution, and documentation of process validations
- Moderation and execution of risk analyses (e.g. GMP-RA, FMEA)
- Ensuring and maintaining the qualified status of existing systems
- Monitoring the validated status of production-relevant processes
- Establishing and controlling the service and maintenance structure for devices
- Evaluation and improvement of equipment availability (OEE) in collaboration with production
- Participation in technical improvements, simple maintenance work, and data maintenance
- Interface function between production and quality management
- At least 3 years of professional experience in qualification and/or validation in a regulated environment (pharma or diagnostics preferred)
- Solid knowledge in GMP, GAMP, 21 CFR Part 11, Annex 11, and Data Integrity
- Technical understanding and analytical thinking skills
- Experience in technical writing is an advantage
- Good ERP knowledge (application and ideally implementation)
- Structured, team-oriented, and interculturally open working style
- Very good German or English skills, ideally both
- A central role in a dynamic production and quality environment
- Plenty of scope for design and professional development opportunities
- A committed team that focuses on quality and collaboration
- Modern infrastructure at the Schönenbuch location
- Flexible working hours and attractive employment conditions
CH-4124 Schönenbuch