Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%

Bachem AG; Bubendorf; Hybrid; CHF 160,000 - 210,000; Full time

Benefits offered by this job

Pension plan

Daycare on campus Bubendorf

Discount platform

Staff restaurant

Wellness or sports facilities

Job summary

Bachem AG hires a Senior Commissioning & Qualification (C&Q) Lead to drive strategic C&Q activities for GMP-regulated facilities at the Bubendorf location. You will oversee commissioning, qualification, and validation across systems, utilities, and equipment while partnering with Engineering, Quality, Automation, and Operations to ensure project success.

The role requires a strong regulatory and technical background in GMP, ISPE guidelines, and risk-based qualification, with fluency in German

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, or related technical discipline.
• Extensive experience in Commissioning & Qualification / Validation within the pharmaceutical industry.
• Proven track record of leading C&Q activities on large scale GMP capital projects.
• Strong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologies.
• Experience with facilities and utilities (e.g. HVAC, media systems); automation and CSV experience is an advantage.
• Excellent written and spoken German and English.

Responsibilities

• Lead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems.
• Develop and implement C&Q strategies, C&Q Master Plans, and risk-based qualification approaches.
• Author, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports.
• Ensure compliance with GMP regulations and internal quality standards.
• Act as the primary C&Q interface to Quality Assurance and support regulatory inspections and audits.
• Coordinate cross-functional stakeholders and manage external vendors and CQV consultants.
• Monitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership.
• Drive standardization, continuous improvement, and best practices across C&Q activities.

Skills

German language

English language

Education

Bachelor's/Master's in Engineering or Life Sciences

Job description

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the Global Engineering department, we are looking for a dedicated Senior Commissioning & Qualification (C&Q) Lead (f/m/d), 100%.

In this role, you are responsible for the strategic planning, execution, and oversight of commissioning, qualification, and validation activities for GMP‑regulated pharmaceutical facilities. Furthermore, this role ensures that all systems, equipment, and utilities are delivered in full compliance with regulatory requirements, quality standards, and project timelines. Acting as a technical and regulatory leader, the position interfaces closely with Engineering, Quality, Automation, Operations, and external partners throughout the project lifecycle.

Your tasks:

• Lead and manage commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, automation, and computerized systems
• Develop and implement C&Q strategies, C&Q Master Plans, and risk‑based qualification approaches
• Author, review, and approve GMP documentation including URS, risk assessments, IQ/OQ/PQ protocols and reports
• Ensure compliance with GMP regulations and internal quality standards
• Act as the primary C&Q interface to Quality Assurance and support regulatory inspections and audits
• Coordinate cross‑functional stakeholders and manage external vendors and CQV consultants
• Monitor progress, manage risks, deviations, and change controls, and provide transparent reporting to project leadership
• Drive standardization, continuous improvement, and best practices across C&Q activities

Your profile:

• Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline
• Extensive experience in Commissioning & Qualification / Validation within the pharmaceutical industry
• Proven track record of leading C&Q activities on large scale GMP capital projects
• Strong knowledge of GMP regulations (EU/FDA), ISPE guidelines, and risk based qualification methodologies
• Experience with facilities and utilities (e.g. HVAC, media systems); automation and CSV experience is an advantage
• Excellent written and spoken German and English

Our offer:

• A dynamic and rapidly growing work environment with internal development and training opportunities

• Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
• Company‑run daycare center on the Bachem Campus in Bubendorf
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra‑mandatory pension provision with our Pension Plan Plus
• Access to benefits platforms with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus

Would you like to drive innovation together with us?

Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!