Validation Engineer
Arklow, Co. Wicklow
Are you an experienced Validation professional looking to join a dynamic pharmaceutical manufacturing environment where quality, collaboration and continuous improvement are at the heart of everything we do?
Our client is seeking a Validation Engineer to join their Quality team, supporting a broad range of validation and qualification activities across manufacturing operations. This is an excellent opportunity to work within a highly regulated GMP environment while contributing to key site projects and continuous improvement initiatives.
Key Responsibilities
Coordinate, execute and report on Process, Cleaning and Transport Validation activities
Support equipment, systems, facility, utility and laboratory qualification activities
Prepare validation protocols and reports
Coordinate cleaning monitoring, ongoing process verification and equipment requalification activities to ensure validated status is maintained
Execute cleaning verification activities
Support industrial transfers, internal transfers and process optimisation projects
Assist in the preparation and review of IQ/OQ/PQ documentation for equipment and systems validation
Investigate and resolve non-conformances and deviations associated with validation studies
Work cross-functionally with departments across the site to ensure validation policies and procedures are adhered to
Ensure products, processes, equipment and systems remain compliant with site validation requirements
Support change control, quality systems, root cause investigations and risk assessments
Prepare, review and maintain SOPs, policies and Validation Master Plans
Deliver training relating to validation activities and implementation
Support internal and external audits and inspections
Stay informed on current industry trends, regulatory requirements and best practices
Requirements
2–3 years’ validation experience within the pharmaceutical industry
Third level qualification in a Scientific or Engineering discipline or equivalent
Strong understanding of validation principles and execution
Experience working within a GMP regulated environment
Excellent technical writing and documentation skills
Strong communication and organisational abilities
Good IT skills
Experience supporting investigations, deviations and change controls would be advantageous
What’s on Offer
Opportunity to work within a highly collaborative pharmaceutical environment
Exposure to a wide range of validation and qualification activities
Career development and continuous learning opportunities
Supportive and inclusive workplace culture
Our client is committed to creating a workplace where everyone feels valued, respected and empowered to bring their authentic selves to work. Applications are welcomed from candidates of all backgrounds and experiences.
Reasonable accommodations are available throughout the recruitment process for candidates who may require them.
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