GMP Commissioning & Validation Engineer (Lab/Manufacturing)

K-Recruiting GmbH; Schweiz; On-site; CHF 110,000 - 140,000; Full time

Job summary

K-Recruiting GmbH is seeking a Commissioning & Qualification Engineer to lead qualification and validation activities for lab instruments, manufacturing equipment, clean room utilities, and facilities at the Werthenstein site in Switzerland. This role requires preparing protocols, executing assessments, and delivering compliant documentation.

You will collaborate with Production, QC, and Engineering, support internal/external audits, and drive continuous improvements in qualification processes.

Qualifications

• Bachelor's degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or related field.
• Minimum 5 years in Qualification/Validation.
• Strong GMP/cGMP knowledge.
• Hands-on qualification/validation and Computer System Validation.
• Regulatory and quality systems understanding in GMP.
• Strong written and verbal communication; documentation.
• English and German at B1 level.

Responsibilities

• Manage qualification and validation of lab instruments and manufacturing equipment.
• Prepare, review, and execute qualification docs including protocols and reports.
• Oversee computer system validation activities in manufacturing and quality environments.
• Ensure activities comply with cGMP and regulatory requirements.
• Collaborate with Production, QC, and Engineering teams.
• Support audits, inspections, and quality improvement initiatives.
• Review GMP-related documents (Deviations, CAPAs, Change Controls).
• Contribute to continuous improvement of qualification and validation processes.

Skills

GMP knowledge

Documentation

Analytical skills

Independent work

Team collaboration

Education

Bachelor's degree in Engineering/Science

Tools

VeevaVault

Kneat

MS Office

Job description

K-Recruiting GmbH is seeking a Commissioning & Qualification Engineer to lead qualification and validation activities for lab instruments, manufacturing equipment, clean room utilities, and facilities at the Werthenstein site in Switzerland. This role requires preparing protocols, executing assessments, and delivering compliant documentation.

You will collaborate with Production, QC, and Engineering, support internal/external audits, and drive continuous improvements in qualification processes.