Validation Engineer

Highly Competitive
  1. Contract
  2. Validation
  3. Switzerland
Boudry, Switzerland
Posting date: 11 Mar 2024
59370

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

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