This is an exciting opportunity for a Validation Engineer to join a leading multinational pharmaceutical company based in Cork. You will provide validation and technical support to the Vaccines IPT team, focusing on cleaning cycle development and cleaning validation.
Key Responsibilities:
- Execute cleaning cycle development, validation, and equipment PQ.
- Develop validation strategies, write protocols, coordinate with vendors, and prepare technical reports.
- Perform equipment and cleaning periodic reviews, CAPAs, deviations, and risk assessments.
- Support commissioning by reviewing and approving documents.
- Participate in cross-functional problem-solving teams for troubleshooting.
- Ensure adherence to regulatory guidelines, site EHS policy, and cGMP standards.
- Serve as a subject matter expert during regulatory inspections.
- Contribute to site audits, risk assessments, and QMS compliance activities.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
- 3-5 years of validation experience in a pharmaceutical or regulated environment.
- Proficiency in at least three of the following: C&Q validation, Cleaning Validation, Equipment Validation, Process Operations, or Process Engineering.
- Working knowledge of GxP systems (e.g., GLIMS, eVAL, electronic batch records) is advantageous.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108