Commissioning & Qualification Engineer

K-Recruiting Life Sciences; Werthenstein; Sur place; CHF 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GMP / cGMP knowledge

Analytical skills

Problem-solving

Documentation

Independent work

Team collaboration

English & German (B1)

Stakeholder management

MS Office

Data integrity

Quality systems

Formation

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

Outils

VeevaVault

Kneat

MS Office

Description du poste

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).