Orion Group Life Sciences is recruiting a VALIDATION ENGINEER on behalf of a multinational biopharmaceutical client based in Mayo for an initial 12‑month contract with potential extension. Hybrid role.
Purpose
The Validation Department is responsible for the qualification/validation of all CGMP equipment, systems and processes utilized for routine operation at the Westport manufacturing site. It also handles revalidation of critical systems & processes. The Validation Engineer ensures customer satisfaction with each revalidation, validation and project work. All activities are performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. Schedule compliance is achieved by engaging with senior management and impacted BU’s, ensuring projects are prioritized as required.
Responsibilities
Over‑see, coordinate, guide and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with relevant engineers, to ensure all validation requirements are met for any new process, equipment or change.
Act as departmental point person on validation projects, completing all associated documentation in line with corporate and regulatory expectations, compiling, authorizing and filing documents in a timely and organized fashion. Coordinate with other validation engineers to achieve compliance by reviewing and approving documentation and coordinating the work.
Participate in risk assessment processes for all business units and in the design review process for all business units.
Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.).
Facilitate the PQR review process, regulatory review process and laboratory equipment review process as per current rota.
Keep abreast of current and changing regulatory guidance for the relevant validation areas, providing support for audit preparation, direct audit interaction and involvement in audit response.
Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department and achieve the company’s quality objective through continuous improvement and conformance to quality standards. Attend department and APEX meetings and participate in quality and safety initiatives.
Provide support for audit preparation, direct audit interaction and involvement in audit response; participate in site internal and external audit program, including periodic review.
Qualifications
Bachelor’s degree required in a science‑based or engineering discipline.
Experience in a pharmaceutical company.
Excellent project‑management skills.
Proficiency in Microsoft Office suite.
Critical thinking and problem‑solving skills.
Ability to articulate clearly when dealing with internal and external bodies.
Excellent conflict‑handling skills.
Expertise in relevant subject‑matter areas (e.g., equipment validation, sterilisation validation, facility validations, aseptic).
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