Senior Commissioning & Validation Engineer | GMP CSVE Expert

K-Recruiting Life Sciences; Werthenstein; On-site; CHF 90,000 - 130,000; Full time

Job summary

K-Recruiting Life Sciences is seeking a Commissioning & Qualification Engineer to lead qualification and validation activities for lab instruments, manufacturing equipment and facilities in a GMP environment. You will prepare/_review protocols, oversee computer system validation, and ensure adherence to regulatory standards.

The role requires a strong engineering/ scientific background, 5+ years of qualification/validation experience, and proficiency in GMP/compliance, with English and German at

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or related field is required.
• Minimum 5 years of Qualification/Validation experience.
• Solid GMP/cGMP knowledge and regulatory familiarity.

Responsibilities

• Manage qualification and validation activities for lab instruments, manufacturing equipment, cleanroom equipment, utilities and facilities.
• Prepare, review, and execute qualification and validation documents (protocols, reports, assessments).
• Oversee computer system validation in manufacturing and quality environments.
• Ensure compliance with cGMP, regulatory requirements and company standards.
• 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 / cGMP knowledge

Analytical skills

Problem-solving

Documentation

Independent work

Team collaboration

English & German (B1)

Stakeholder management

MS Office

Data integrity

Quality systems

Education

Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or related scientific discipline

Tools

VeevaVault

Kneat

MS Office

Job description

K-Recruiting Life Sciences is seeking a Commissioning & Qualification Engineer to lead qualification and validation activities for lab instruments, manufacturing equipment and facilities in a GMP environment. You will prepare/_review protocols, oversee computer system validation, and ensure adherence to regulatory standards.

The role requires a strong engineering/ scientific background, 5+ years of qualification/validation experience, and proficiency in GMP/compliance, with English and German at