Commissioning & Qualification Engineer

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

Client Description

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.

Client Description

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.

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.

Your profile

• 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).

Key Competencies

• Attention to detail
• Strong ownership and accountability
• Effective communication
• Problem solving and root cause analysis
• Compliance mindset
• Cross-functional teamwork