CSV engineer

Our client in Switzerland, (Bern), require a dedicated CSV contractor to join their team in the New Year. The client prefer local candidates (Swiss permit holders) or EU citizens who can relocate to Switzerland within short notice. MSI are able to offer a competitive hourly rate for the position, acknowledging your valuable expertise and flexibility.

Responsibilities:
· Assess and produce CSV packages for assigned projects, ensuring compliance with validation plans and regulatory standards.
· Plan, coordinate, and execute all phases of computer system validation for production and QC Lab systems.
· Prepare, review, and approve technical and GMP-related documentation.
· Define electronic records requirements for computerised systems, considering regulatory and company standards.
· Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems.
· Contribute to managing changes in systems, procedures, and processes.
· Performance Measurement:
· Delivery on annual goals and objectives, guided by Our Credo and Leadership Imperatives.

Education & Experience:
· Bachelor/masters degree in technical or natural sciences.
· Minimum of 3 years of experience in pharma or biotech.
· Experience in defining strategy and validating computerised manufacturing equipment.
· Minimum of 4 years of experience with CSV.
· Knowledge of FDA 21CFR part 11, EUGMP Annex 11, and ISPE GAMP 5 guidelines.

Skills & Competences:
· Business fluency in English, German language is a plus.
· Basic knowledge of Qualification requirements according to cGMP regulations.
· Basic understanding of quality assurance principles.

If available to start a new assignment in January 2024 and have the required skills, please contact me, and i will respond ASAP.