Commissioning & Qualification Engineer

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

Commissioning & Qualification Engineer (M/F/D)

Tasks

• Manage qualification and validation activities for Lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities.
• Prepare, review, and execute qualification and validation documentations, including protocols, reports, and assessments.
• Provide oversight for computer system validation activities in manufacturing and quality environments.
• Ensure all activities are performed in compliance with cGMP, regulatory requirements, and company standards.
• Collaborate with cross-functional teams including Production, QC, and Engineering.
• Support internal and external audits, inspections, and quality improvement initiatives.
• Review GMP-related documents as required (e.g. Technical assessments, Deviations, CAPAs, Change Controls).
• Contribute to continuous improvement of qualification and validation processes.

Qualification

• Bachelor's degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline.
• Minimum 5 years of experience in Qualification/Validation.
• Strong working knowledge of GMP / cGMP principles and practices.
• Hands-on experience in: - Qualification / Validation activities - Computer System Validation
• Good understanding of regulatory expectations and quality systems in GMP area.
• Strong analytical, problem-solving, and documentation skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• English and German language proficiency at B1 level required.

Preferred Skills

• Experience in audit support and inspection readiness.
• Experience in GAMP5, Annex 11 and Annex 15
• Familiarity with data integrity requirements.
• Good communication and stakeholder management skills.
• Proficiency in MS Office tools and quality documentation systems (VeevaVault, Kneat).

Requirements

Start: 01.12.2026

Duration: 12 months

Capacity: 5 days per week

Location: Werthenstein, Switzerland