Qualification & CSV Engineer — Onsite GMP Specialist

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

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.