This is an exciting opportunity for an experienced Validation Engineer who isinterested in a new challenge in a cGMP regulatory environment.
Role Requirements
- Review of IOQ documentation for Utilities and Equipment e.g. Autoclave, Lyos, COP/SOP during C&Q phase. Ensure documentation complies with standards.
- Execute cycle development and PQ of utility systems and equipment, cleaning validation, facilities for post OQ activities. This includes writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations
- 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.
- Adherence to highest standards for Compliance (Quality and Safety)
Skills Required
- 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment and 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 the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108