Clean Validation Engineer
- €35 - €40 PER HOUR
- Cork
- Contract
Job Title: Clean Validation Engineer
Working Structure: Monday - Friday, 39 H/W
Contract Duration: 12 months
Pay Rate: €35 - €40/hour
Job Description:
An amazing opportunity has arisen for a Validation Engineer to join a leading multinational bio-pharmaceuticals facility! The successful candidate will provide primarily cleaning validation, executing cleaning cycle development and technical support to the Vaccines IPT team.
Some of the responsibilities for the Clean Validation Engineer includes:
- Execute cleaning cycle development, cleaning validation, and PQ of equipment.
- Write validation strategies, coordinate with vendors, write protocols, submit samples, analyse test results, and prepare technical reports.
- Perform equipment periodic reviews, cleaning periodic reviews, CAPAs, deviations, change control, and risk assessments.
- Review and approve commissioning phase documents to ensure compliance with standards.
- Participate in cross-functional problem-solving teams for troubleshooting and investigations within the Vaccines IPT.
- Adhere to regulatory guidelines and represent the IPT on cross-functional project teams.
- Provide technical support and act as a subject matter expert during regulatory inspections.
- Ensure compliance with site EHS policy, cGMP, and other regulations.
Qualifications and Experience:
- 3-5 years' experience as a validation specialist in a pharmaceutical or highly regulated environment.
- A B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
- Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment Validation, Process Operations or Manufacturing, Process Engineering.
- A working knowledge of GxP systems such as GLIMS and eVAL, electronic batch records, would be advantageous.
This position offers a challenging and rewarding opportunity to contribute to the Vaccines IPT team, ensuring high standards of compliance and technical excellence.
Please note: You must be able to work in the EU without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727 (UK) / +31 (0)20 808 9982 (NL)
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