Senior Commissioning & Qualification Lead — GMP Validation

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 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