Global C&Q Lead for GMP Capital Projects

Bachem Holding AG; Stein; On-site; CHF 180,000 - 240,000; Full time

Job summary

Bachem Holding AG is expanding with a new Sisslerfeld site and seeks an experienced Senior Commissioning & Qualification Engineer to drive C&Q activities across global capital projects. You will plan, execute, and manage C&Q from concept to handover, ensuring adherence to GMP standards and regulatory requirements.

The role requires a deep understanding of CAPEX projects, international collaboration, and leadership of diverse teams.

Qualifications

• Completed degree in engineering, natural sciences, or a related field.
• At least 10 years of professional experience in the pharmaceutical or biopharmaceutical industry.
• Proven experience in international CAPEX projects (medium to large scale, complex requirements).
• Extensive C&Q expertise in Small Molecules; Packaging, warehousing, GMP & non-GMP infrastructure; Automation systems & new technologies.
• Strong knowledge of global regulations (FDA, EMA, ICH, ISPE Integrated Commissioning & Qualification, etc.).
• Ideally experience with KNEAT Gx.
• Deep understanding of project management, PQS/EM compliance, and interfaces with Quality.
• Excellent communication, collaboration, and leadership skills.
• Analytical thinking and financial acumen to derive sustainable, efficient solutions.
• Willingness to drive change, creative thinking, and the ability to support organizations through transformation.
• Confident working style in global, culturally diverse teams.

Responsibilities

• Leadership of C&Q activities within multidisciplinary large capital projects.
• Coordination and management of C&Q‑related deviations and changes within defined timelines and in compliance with required quality standards.
• Responsibility for budget, schedule, prioritization, resources, and the quality of C&Q execution.
• Analysis of options, planning of execution strategies, and development of detailed C&Q schedules.
• Preparation of tender documents, support in procurement processes, and cost estimation.
• Ensuring a smooth handover to Operations and Quality.
• Risk management, including the derivation of proactive measures in case of deviations.
• Management and onboarding of the C&Q team, including external partners.
• Responsibility for training C&Q teams and ensuring adherence to internal standards.
• Clear, structured, and audience‑appropriate communication with all stakeholders.
• Close collaboration with global sites to harmonize C&Q standards and digital processes.
• Support in supplier evaluation and coaching of local SMEs.
• Active promotion of lean and agile methods within engineering and C&Q contexts.
• Technical review activities in CAPEX projects.
• Participation in or leadership of international teams in GMP engineering, C&Q, and global initiatives.

Skills

C&Q expertise

Small Molecules

Packaging & warehousing

Automation systems

GMP & non-GMP infrastructure

Regulatory knowledge (FDA EMA ICH ISPE

KNEAT Gx

Project management

Communication & leadership

Analytical thinking & financial acumen

Change management / transformation

Global collaboration / multicultural

Education

Engineering or natural sciences degree

Job description

Bachem Holding AG is expanding with a new Sisslerfeld site and seeks an experienced Senior Commissioning & Qualification Engineer to drive C&Q activities across global capital projects. You will plan, execute, and manage C&Q from concept to handover, ensuring adherence to GMP standards and regulatory requirements.

The role requires a deep understanding of CAPEX projects, international collaboration, and leadership of diverse teams.