Senior Commissioning & Qualification (C&Q) Lead (a), 100%

Bachem Holding AG; Indiana (PA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible working hours

Training opportunities

Pension fund contributions coverage

Company daycare center

Discounts from external partners

Access to sports activities

Staff restaurant with healthy food

Job summary

Bachem Holding AG is seeking an experienced professional to lead commissioning, qualification, and validation activities in Indiana, United States. The ideal candidate should have a strong background in engineering or life sciences, with extensive experience in GMP capital projects and bilingual proficiency in German and English.

The role offers a dynamic work environment with flexible hours, development opportunities, and comprehensive benefits, including coverage for pension contributions and a company daycare center.

Qualifications

• Extensive experience in Commissioning & Qualification/Validation within the pharmaceutical industry.
• Proven track record of leading C&Q activities on large scale GMP capital projects.
• Excellent written and spoken German and English.

Responsibilities

• Lead and manage commissioning, qualification, and validation activities
• Develop and implement C&Q strategies and Master Plans
• Ensure compliance with GMP regulations and internal standards
• Drive standardization and continuous improvement in C&Q activities

Skills

Commissioning & Qualification

GMP regulations knowledge

Risk-based qualification methodologies

Project management

German proficiency

English proficiency

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Tools

GMP documentation

HVAC systems

Automation

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.

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

Qualifications

• 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 methodologiesExperience with facilities and utilities (e.g. HVAC, media systems); automation and CSV experience is an advantage
• Excellent written and spoken German and English

Benefits

• 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

We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.