Qualification / CSV Engineer

Randstad Switzerland; Luzern; On-site; CHF 110,000 - 140,000; Full time

Job summary

Randstad Switzerland is seeking a Qualification / Computer System Validation Engineer to support qualification and validation activities within a GMP pharmaceutical environment.

The role covers qualification of lab instruments, manufacturing and clean room equipment, utilities and facilities, plus computer system validation, while ensuring cGMP compliance and collaboration with Production, QC and Engineering.

Qualifications

• Bachelor's degree in a relevant scientific/engineering field.
• Minimum 5 years' experience in qualification and validation.
• Strong knowledge of GMP/cGMP and computer system validation.

Responsibilities

• Manage qualification and validation activities for lab instruments, manufacturing and facilities.
• Prepare, review, and execute qualification and validation documents (protocols, reports, assessments).
• Provide oversight for computer system validation in manufacturing and quality environments.
• Ensure activities comply with cGMP, regulatory requirements and company standards.
• Collaborate with Production, QC and Engineering; support audits and inspections.
• Review GMP-related documents (deviations, CAPAs, change controls).
• Contribute to continuous improvement of qualification and validation processes.

Skills

Qualification/Validation

Computer System Validation

GMP / cGMP

English (B1)

German (B1)

Education

Bachelor's degree in Engineering/Pharma/Chemistry/Biotech/Microbiology

Tools

VeevaVault

Kneat

MS Office

GAMP5

Annex 11

Annex 15

Job description

For one of our clients, an international pharmaceutical company, we are seeking a Qualification/Computer System Validation Engineer.

General Information:

• End Date: 30.11.2027
• Working hours: Standard
• Home Office: primarily onsite

We are seeking a motivated and detail-oriented Qualification / Computer System Validation Engineer to support qualification and validation activities within a pharmaceutical environment. The ideal candidate will have strong experience in equipment, utility, and clean room system qualification, as well as computer system validation in a GMP-regulated environment.

Tasks & responsibilities:

• 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.

Required Qualifications:

• 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 the 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).
• Strong ownership and accountability
• Effective communication
• Problem solving and root cause analysis
• Compliance mindset
• Cross-functional teamwork