Validation Engineer (Documentation / CQV Support) – Bern, Switzerland – 4–6 Month Contract
Title: Validation Engineer (Documentation / CQV Support)
Location: Bern, Switzerland
Positions Available: 2
Type: Contract / Freelance (4–6 Months)
Your Responsibilities:
• Support technical engineering teams by producing validation and qualification documentation within a GMP-regulated pharmaceutical / chemical production environment
• Gather technical and process information from SMEs and convert it into compliant validation documentation
• Create, review and manage User Requirements Specifications (URS), Functional Specifications (FS) and validation-related documents
• Support qualification and documentation workflows across ongoing pharmaceutical manufacturing projects
• Work closely with engineering and process teams to ensure documentation is aligned with project and compliance requirements
• Support project delivery within active live project phases with minimal onboarding time required
• Utilise systems such as Kneat and TrackWise to support documentation and change management activities
• Assist validation and CQV teams by ensuring documentation packages are delivered accurately and on schedule
Your Requirements:
• Experience working within GMP / GxP regulated pharmaceutical environments
• Strong validation and qualification documentation experience
• Experience using Kneat for documentation management
• Experience using TrackWise for change management processes
• Strong experience authoring URS, FS and validation documentation
• Excellent technical writing and documentation skills
• Ability to work independently within fast-paced live project environments
• Comfortable gathering technical information directly from engineering and process SMEs
• German and English language skills are essential
If you are interested in this role, please do not hesitate to send me your CV today for an immediate response!
aholt@optimussearch.com
