QA Engineering Manager

Responsibilities

• Maintain GMP status and control requalification and maintenance activities, including change control and deviation procedures
• Participate in project-specific qualification and validation activities
• Create, review, and approve high-level qualification and validation documents
• Develop and approve GMP-relevant documentation such as SOPs and logbooks
• Support the preparation, management, and follow-up of regulatory inspections and internal customer audits
• Analyze existing processes to identify optimization potential and oversee the implementation of improvements

Requirements

• Master's degree in Engineering, Chemistry, Process Engineering, Pharmacy, or a comparable field
• Several years of professional experience in a cGMP-regulated environment
• Deep knowledge of Commissioning & Qualification (C&Q)
• Expertise in Swiss, EU, and USA GMP regulations
• Proficiency in German (written and spoken) and English (C1 level)
• Experience in Cleaning Validation and/or Computer System Validation (CSV)
• Proficiency in process and document management software such as SAP or Master Control

Benefits

• Dynamic and growing work environment with internal development opportunities
• Flexible working hours and options for additional vacation days
• Employee development through numerous internal and external training programs
• Access to the Swibeco benefits platform for various discounts
• On-site staff restaurant offering fresh and healthy food

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, we provide products for research, clinical development, and commercial applications to pharmaceutical and biotech companies worldwide. Headquartered in Switzerland, we operate internationally with locations in Europe, the USA, and Asia.