Senior CQV Leader — GMP Commissioning & Validation

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 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.