Pharmaceutical Cleanroom Validation Specialist

5 days ago

Cork, Cork, Ireland beBeeCleanroom Full time €60,000 - €80,000

Job Summary:

We are seeking a highly skilled Cleanroom Validation Specialist to join our team in the pharmaceutical manufacturing industry. As a Cleanroom Validation Specialist, you will play a critical role in ensuring the ongoing validation compliance of computerized equipment and systems in sterile products manufacturing.

Main Responsibilities:

  • Validate all new computerized equipment and control systems on site.
  • Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized equipment and systems.
  • Participate in the change control process advising on CSV issues, as appropriate.
  • Develop and execute DQ, IQ, OQ, and PQ activities.
  • Maintain project records in compliance with company and legal requirements.
  • Design, implement, and execute validation studies for manufacturing and control equipment.
  • Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilization.

About You:

  • Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
  • Post-graduate studies as appropriate to augment primary Degree
  • 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • 2-3 years experience in validation environment
  • Troubleshooting skills associated with projects, process development, etc.
  • Competent technical knowledge of pharmaceutical plants.
  • GAMP and ISPE Baseline guides.
  • Quality and compliance regulations
  • Project management skills
  • Good communication skills
  • Natural influencer and works well as part of a multifunctional team.
  • Highly motivated and self-resilient.
  • Adaptable and flexible as well as a pragmatically minded problem solver.

Benefits:

This is a mid-senior level contract position in the Engineering, Information Technology, and Quality Assurance function within Pharmaceutical Manufacturing industry.

Seniority Level: Mid-Senior
Employment Type: Contract
Job Function: Engineering, Information Technology, and Quality Assurance
Industries: Pharmaceutical Manufacturing

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