Description:
Our client is a biopharmaceutical company based in Cork looking for a Senior Cleaning Validation Specialist to provide validation, primarily cleaning cycle development and cleaning validation and technical support to their vaccines team.
Responsibilities:
- Execute 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.
- Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
- Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
- Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines.
- Technical report writing, statistical analysis of data.
- Adherence to the latest regulatory guidelines.
- 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).
- Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Qualifications & Experience:
- B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
- 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment.
- 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.