Validation Engineer

Proclinical are recruiting for a Validation Engineer to join an organisation. This role is on a contract basis and is located in Boudry.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

Contribute to site project execution of new manufacturing equipment, room, utilities and cleaning validation program as a Quality representative.Evaluate and approve qualification and validation documentation such as risk assessment, protocol, report, etc.Review, evaluate, and approve deviation, discrepancy and change controls that occurred throughout qualification/validation of equipment/systems in area of responsibility.Assist on data integrity assessments for new equipment / systems.Evaluate and approve processes affiliated with project deployment.Work while under minimal supervision both in a team as well as independently.Offer QA assistance to SMEs to guarantee the compliance to process/industry standards.The ideal candidate will adhere to the client's core manners.Other duties may be assigned.Key Skills and Requirements:Comprehension of solid oral dosage form manufacturing/packaging and QC procedures.Familiarity with Change Control, Deviation Management and Risk management Quality Systems.Comprehension of equipment qualification, which involves automation element, cleaning validation and computerised system validation.Computer literacy.Acquaintance within change management throughout project execution as well as protocol deviation and discrepancy.Prior involvement with risk-based approach to qualification/validation as well as Data Integrity.Comprehension of the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.Analytical, interpersonal and communication skills both verbally and in writing.Fluency in both English and French.Works well both independently as well as in a team.Capable of handling ambiguity to recognise and mitigate risks.A sense of ethics, diplomacy and discretion.Able to think critically to analyse multifaceted situations and resolve issues.Capable of handling multiple projects simultaneously as well as produce and work within internal timelines.Educated to a degree in a scientific field.Demonstrable experience within quality assurance linked to qualification/validation in a pharmaceutical organisation or any other regulated organisation.Comprehension of cGMPs and Swiss, EU, and FDA regulatory necessities. If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer. #Engineering

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