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Job Description
Join a leading multinational pharmaceutical organization in Cork as a Validation Specialist and contribute to the development of innovative products.
As a key member of the team, you will be responsible for executing cycle development, cleaning validation, and performance qualification of equipment, as well as writing and adhering to validation strategies.
Key responsibilities include:
- Executing cycle development, cleaning validation, and performance qualification of equipment
- Writing and adhering to validation strategies, coordinating with outside vendors, and writing protocols independently
- Executing run the business activities, including equipment periodic reviews, cleaning periodic review, CAPAs, and deviations
- Providing support during commissioning phase by reviewing and approving documents
- Ensuring documentation complies with standards
- Participating in cross-functional problem-solving teams for troubleshooting and investigations
- Writing technical reports and performing statistical analysis of data
- Representing the IPT on cross-functional project teams
- Providing technical input and support and presenting as an SME on relevant topics during regulatory inspections
- Ensuring compliance with site EHS policy, cGMP, and other business regulations
Requirements:
- Experience as a validation specialist in a pharmaceutical or highly regulated environment
- Bachelor's 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
- Working knowledge of GxP systems associated with this role, including GLIMS and eVAL