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Job Description
Join a global biopharmaceutical company in Cork as a validation specialist and technical support expert, ensuring highest standards of quality, compliance, and safety in vaccine manufacturing.
Execute cycle development, cleaning validation, and equipment qualification, writing and adhering to validation strategies, coordinating with vendors, and analyzing test results.
Key Responsibilities:
- Develop and execute validation cycles, including cleaning validation and equipment qualification
- Write and implement validation strategies, coordinate with vendors, and write protocols independently
- Analyze test results, prepare technical reports, and execute equipment periodic reviews and cleaning periodic reviews
- Manage CAPAs, deviations, change control, and risk assessments
- Provide support during commissioning phase, reviewing and approving documents
- Ensure documentation complies with standards and regulatory guidelines
- Participate in cross-functional problem-solving teams for troubleshooting and investigations
- Write technical reports, perform statistical analysis of data, and represent Operations on cross-functional project teams
- Provide technical input and support, and present as a subject matter expert during regulatory inspections
- Ensure compliance with site EHS policy, cGMP, and other business regulations
- Support Technical Operations input to risk assessments, audits, regulatory inspections, and incident investigations
- Participate and comply with Manufacturing Division Quality Management System (QMS) requirements
Requirements:
- 3-5 years' experience as a validation specialist in a pharmaceutical or highly regulated environment
- BSc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field
- Experience in at least three of the following: C&Q validation, Cleaning Validation, Equipment validation, Process operations, or manufacturing
- Working knowledge of GxP systems, including GLIMS and eVAL, electronic batch records