Senior Qualification & Validation Engineer – GMP/CGMP

LHH; Luzern; On-site; CHF 110,000 - 160,000; Full time

Job summary

LHH is seeking a motivated Qualification / Computer System Validation Engineer to support qualification and validation activities in a pharmaceutical environment. The role emphasizes equipment, utilities, and clean room qualification as well as computer system validation in GMP-regulated settings.

You will collaborate with Production, QC and Engineering, prepare and review qualification documents, and ensure compliance with cGMP.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or related discipline.
• Minimum 5 years in Qualification/Validation.
• Strong GMP / cGMP knowledge and practical QA document control.
• Experience with Computer System Validation and regulatory audits.

Responsibilities

• Manage qualification/validation for lab instruments, equipment, clean rooms, utilities, and facilities.
• Prepare, review, and execute qualification/validation documents (protocols, reports, assessments).
• Oversee computer system validation in manufacturing and quality environments.
• Ensure activities comply with cGMP, regulations, and standards.
• Collaborate with Production, QC, and Engineering teams.
• Support audits, inspections, and quality improvement programs.
• Review GMP docs (technical assessments, deviations, CAPAs, change controls).
• Contribute to continuous improvement of qualification/validation processes.

Skills

GMP / cGMP knowledge

Qualification / Validation

Computer System Validation

Regulatory compliance

Cross-functional collaboration

Education

Engineering

Pharmacy

Chemistry

Biotechnology

Microbiology

Related scientific discipline

Tools

VeevaVault

Kneat

MS Office

Job description

LHH is seeking a motivated Qualification / Computer System Validation Engineer to support qualification and validation activities in a pharmaceutical environment. The role emphasizes equipment, utilities, and clean room qualification as well as computer system validation in GMP-regulated settings.

You will collaborate with Production, QC and Engineering, prepare and review qualification documents, and ensure compliance with cGMP.