Manufacturing Validation Engineer-Multiple Locations

Manufacturing Validation Engineer-Multiple Locations

Edelway is a Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for Validation Engineers to join them on a long term basis. (Contract)

Please note that the role can be based in either Switzerland (SO/ZH/VS/TI/BL), Germany or Austria.
Language: English, German is a plus.
Start Date: ASAP
Rate: Excellent

THE ROLE
*To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements are addressed.
*Assuming responsibility as the technical expert for the validation process and its compliance with company standards.
*Resolve & manage technical and operational problems
*Suggest and implement innovation and continuous improvements within the validation process
*Implement initiatives in the validation process that will deliver customer value at the lowest cost
*Build cross functional and cross-departmental support within Quality Systems and manage relationships both internally and externally to facilitate successful team behaviour within the quality systems functional area
*Review and approve validation master plans, protocols, summary reports and other documentation associated with validations, as appropriate for each validation exercise
*Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
*Ensure all validation activities are carried out and reported in a timely manner
*Ensure compliance through assisting in audits.
*Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
*Lead by example, inculcating the Credo values in all actions within the workplace

YOU'LL NEED

*Experience in Process Validation, Medical Devices, Mechanical and Chemical Processes
*In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
*Have a comprehensive understanding of GMP, compliance, validation Practices including the system development life cycle and regulatory expectations.
*Working experience of validation computer systems for use in a FDA regulated environment.
*Have some knowledge of bespoke validation.
*Qualification in an appropriate discipline (eg Junior Engineer or Technician)

If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.

Validation, medical devices, Pharma, Pharmaceutical, Engineer, Technician, Quality, manufacturing.