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 c.jack@proclinical.com.

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