Commissioning & Qualification Engineer

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

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