Bachem seeks a Senior C&Q Lead in Bubendorf to drive strategic planning and execution of qualification activities for GMP-regulated pharmaceutical facilities within the Global Engineering department.
Positioned within the Global Engineering department, this role supports the company’s continuous organic growth by providing technical and regulatory leadership. The position serves as the central interface between Engineering, Quality, Automation, Operations, and external partners, ensuring robust oversight of commissioning, qualification, and validation efforts.
Responsibilities
- Manage end-to-end commissioning, qualification, and validation processes for facilities, utilities, equipment, and computerized systems.
- Create and execute C&Q strategies, including Master Plans and risk-based qualification frameworks.
- Draft, review, and approve essential GMP documentation such as User Requirement Specifications (URS), risk assessments, and IQ/OQ/PQ protocols and reports.
- Serve as the main point of contact for Quality Assurance regarding C&Q matters and support regulatory inspections.
- Coordinate with cross-functional teams and manage relationships with external vendors and CQV consultants.
- Track project progress, handle deviations and change controls, and deliver clear status reports to leadership.
- Promote standardization and continuous improvement of C&Q best practices across the organization.
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical field.
- Significant experience in Commissioning, Qualification, and Validation within the pharmaceutical sector.
- Demonstrated success leading C&Q activities on large-scale GMP capital projects.
- Deep understanding of EU/FDA GMP regulations, ISPE guidelines, and risk-based qualification methodologies.
- Fluency in both German and English, with excellent written and spoken skills.
Nice to have
- Prior experience with facilities and utilities, such as HVAC or media systems.
- Background in automation and Computer System Validation (CSV).
What the company offers
- Access to internal development programs and training opportunities.
- Flexible working hours combined with the option to work from home.
- Ability to earn additional vacation days through workload adjustments.
- On-site company-run daycare center at the Bubendorf campus.
- 60% coverage of pension fund contributions by Bachem AG, plus options for extra-mandatory pension provisions.
- Discounts via external partner benefits platforms.
- Fresh, healthy, and varied meals in the staff restaurant.
- Free sports activities available on the Bachem Campus.
About the company
Bachem is characterized as a dynamic and rapidly growing organization. The company fosters an environment that supports professional development and offers a comprehensive range of employee benefits to support work-life balance and well-being.
- Dynamic and fast-paced growth environment.
- Strong focus on employee development and training.
- Supportive work-life balance with flexible hours and remote work options.
- Comprehensive benefits including on-site childcare, pension contributions, and wellness activities.
How to apply
Documents to submit:
- Complete application documents
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