Validation Engineer
Asset Recruitment
- Co Cork
- Contract
- Full-time
- Perform cleaning cycle development, cleaning validation and PQ of equipment.
- Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
- Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
- Represent the IPT on cross-functional project teams.
- Guarantee compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by supporting and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as needed.
- Minimum of 3-5 years’ experience as a Validation specialist in a pharmaceutical or a highly regulated environment.
- B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or related.
- Experience across at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
- A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.