Senior Commissioning & Qualification (C&Q) Engineer – Biopharmaceutical Manufacturing (Stein, Switzerland)
Location:
Stein, Switzerland
Employment Type:
Full-time, Permanent
Level:
Senior / Lead Engineer
About the Role
We are seeking an experienced
Senior Commissioning and Qualification (C&Q) Engineer
to lead equipment and system qualification activities for a state-of-the-art biopharmaceutical manufacturing facility in Stein. In this role, you will provide technical leadership in C&Q strategy development, execution, and lifecycle management for GMP utilities, process equipment, and facilities.
This is an excellent opportunity for a senior professional ready to take on a leadership or near-managerial role in a highly dynamic and growing environment focused on delivering high-quality biologics and innovative therapies.
Key Responsibilities
* Lead and oversee commissioning, qualification, and validation (CQV) activities for new and existing GMP systems, including utilities, process equipment, and cleanroom facilities.
* Develop and implement risk-based C&Q strategies in alignment with project schedules, regulatory requirements (FDA, EMA, PIC/S), and internal quality standards.
* Coordinate cross-functional teams including engineering, QA, validation, operations, and automation to ensure seamless project execution.
* Author and review C&Q documentation such as URS, DQ, IQ, OQ, and PQ protocols and reports.
* Provide technical guidance and mentorship to C&Q engineers and contractors; act as SME for qualification standards and practices.
* Ensure adherence to data integrity, change control, and deviation management processes.
* Contribute to continuous improvement initiatives to optimize qualification lifecycle management and facility readiness.
* Support audits, inspections, and regulatory submissions with subject matter expertise in C&Q activities.
Requirements
* Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Process, or related discipline).
* Minimum
8–10 years of experience
in commissioning and qualification within the
pharmaceutical or biopharmaceutical
industry.
* Proven experience leading C&Q activities on large-scale capital projects in a GMP-regulated environment.
* Strong understanding of
EU GMP Annex 15
,
ICH Q9/Q10
, and
ISPE Baseline Guides
.
* Excellent communication, leadership, and stakeholder management skills.
* Fluent in English; German is an advantage.