Validation Specialist (C&Q / CQV Engineering)

Validation Specialist (C&Q / CQV Engineering)

Our Pharmaceutical client in Bern (Switzerland), is looking for a motivated team member.

Tasks & Responsibilities:

The position will report to the C&Q Manger and oversees Commissioning & Qualification (C&Q) activities for Technical Services department to ensure that:

• Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
• Qualification/Validation Master plans are up to date and established for all ongoing projects
• Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
• Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
• Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
• Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
• Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
• Coordination and oversight of external suppliers

Must have:

• Bachelor/Master's degree in technical or natural sciences
• 5 years working experience in a Pharma/Medical Devices company in C&Q/CQV equivalent position
• Know-how of Qualification requirements according to cGMP regulations
• Experience working with cross-department stakeholders
• Know-how of quality assurance principles

Nice to have:

• Experience working in project teams and multiple projects in parallel
• Experience working with ISPE baseline guide vol 3, vol 4 and vol 5
• Know-how of thermomapping studies

Language skills:

• Business fluency in English
• German language is a plus

General Information:

• Start date: ASAP
• End date: 6 Months
• Workload: 100%
• Work Location: Bern

For further information, please contact your Experis Recruiter, Elaine Kanwar +41 61 282 22 23 or email your CV or apply directly online.