System Validation Engineer

CK QLS; Luzern; On-site; CHF 90,000 - 120,000; Full time

Job summary

CK QLS in Switzerland is seeking a Qualification & Validation Specialist to support GMP qualification and validation activities across laboratory instruments, manufacturing equipment, cleanroom equipment, utilities and facilities.

The role requires hands-on CSV experience, a strong GMP/cGMP background, and collaboration with Production, QC and Engineering teams. English and German at B1 level are expected, with valid work authorization to work in Switzerland.

Qualifications

• Bachelor’s degree in engineering, pharmacy, chemistry, biotechnology, microbiology or related field.
• Minimum five years’ experience in qualification and validation.
• Hands-on CSV experience and strong GMP/cGMP knowledge.
• Strong documentation, analytical and problem-solving skills.
• English and German at least B1 level.
• Experience with GAMP 5, Annex 11/15, data integrity, Veeva Vault, Kneat advantageous.

Responsibilities

• Prepare, review and execute qualification and validation protocols, reports and assessments.
• Provide oversight of CSV activities within manufacturing and quality environments.
• Ensure compliance with cGMP, regulatory requirements and company standards.
• Collaborate with Production, QC and Engineering teams.
• Review deviations, CAPAs and change controls.
• Support audits, inspections and improvements to qualification and validation processes.

Skills

CSV experience

Documentation

Analytical skills

Problem-solving

GMP knowledge

Education

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

Tools

GAMP 5

Annex 11

Annex 15

Data integrity

Veeva Vault

Kneat

Job description

CK QLS is recruiting for a Qualification & Validation Specialist to support GMP qualification and validation activities across laboratory instruments, manufacturing equipment, cleanroom equipment, utilities and facilities.

The role

• Prepare, review and execute qualification and validation protocols, reports and assessments.
• Provide oversight of Computer System Validation (CSV) activities within manufacturing and quality environments.
• Ensure compliance with cGMP, regulatory requirements and company standards.
• Collaborate with Production, QC and Engineering teams.
• Review technical assessments, deviations, CAPAs and change controls.
• Support audits, inspections and improvements to qualification and validation processes.

Your background

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology or a related discipline.
• Minimum five years’ experience in qualification and validation.
• Hands-on CSV experience and strong knowledge of GMP/cGMP principles.
• Strong documentation, analytical and problem-solving skills.
• English and German proficiency at B1 level or above.
• Experience with GAMP 5, Annex 11, Annex 15, data integrity, Veeva Vault and Kneat would be advantageous.

All applicants must have valid work permit to work in Switzerland