Commissioning & Qualification Engineer

Role Overview

Join a dedicated team to support qualification and validation activities within a pharmaceutical environment. This position requires a motivated and detail-oriented professional with strong experience in equipment, utility, and clean room system qualification, as well as computer system validation in a GMP-regulated setting.

Key Responsibilities

• Manage qualification and validation activities for lab instruments, manufacturing equipment, clean room equipment, utilities, and facilities.
• Prepare, review, and execute qualification and validation documentation, 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, such as technical assessments, deviations, CAPAs, and change controls.
• Contribute to the continuous improvement of qualification and validation processes.

Required Profile

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biotechnology, Microbiology, or a related scientific discipline.
• Minimum of 5 years of experience in Qualification/Validation.
• Strong working knowledge of GMP / cGMP principles and practices.
• Hands-on experience in qualification/validation activities and 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.

Preferred Skills

• Experience in audit support and inspection readiness.
• Experience with 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 such as VeevaVault and Kneat.

Key Competencies

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