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 GMP rules for Switzerland, EU, and USA
• Proficiency with process and document management software such as SAP or Master Control
• Specific experience in Cleaning Validation and/or Computer System Validation (CSV)
• Excellent communication skills in German and professional proficiency in English (C1)

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. We provide products for research, clinical development, and commercial applications to pharmaceutical and biotechnology companies worldwide. Headquartered in Switzerland with locations in Europe, the USA, and Asia, Bachem leverages over 50 years of industry expertise.