Our client a pharmaceutical company in Mayo is looking to hire a Validation Engineer for their site
The Validation Department is responsible for the qualification / validation of all CGMP equipment, systems and processes utilized for routine operation at the manufacturing site. The Department is also responsible for the revalidation of critical systems & processes.
The Validation Engineer will provide technical oversight and guidance to other validation engineers and Business Units in the relevant subject matters and oversee related validation associated with these. The Senior Validation Engineer will also facilitate the coordination of the Revalidation Schedule on BMRAM, ensuring all activities are completed within the required time-frame. The Senior Validation Engineer will also assist the Validation Manager in other areas such as training, maintaining department metrics, coordination of the laboratory validation documentation review schedule, coordination of schedule and assisting in Audit preparation or responses. The Senior Validation Engineer will ensure that all Validation / Revalidation activity under their scope is performed in line with Global Standards, FDA, HPRA and other MOH regulatory requirements. This schedule compliance will be achieved by actively engaging with, challenging, supporting and motivating team members.
- Over-see, Coordinate, guide and implement the site validation master plan under prospective and concurrent validation studies in a timely manner, with the relevant engineers.
- To ensure that all validation requirements are met for any new process, equipment or change to existing processes or equipment.
- Manage the Revalidation schedule across the relevant Business Unit including co-ordination with System Owners and Laboratories for testing. Review and approve associated revalidation documentation.
- To actively lead validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulator expectations.
- To ensure that all SDLC documentation pertaining to each validation study under his/her responsibility is compiled and filed in a timely and organized fashion.
- To provide guidance to other validation engineers on his/her Subject Matter Expertise.
- Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards.
- Provide the relevant support for Regulatory Audits / Submissions and other regulatory requests.
- Support and comply with internal EHS requirements, procedures and policies.
- Bachelor’s degree required in science based or engineering discipline
- Minimum 4 years’ experience in the area of validation / similar role
- Excellent project management skills
- Ability to articulate clearly when dealing with internal and external bodies.
- Excellent conflict handling skills
- Expertise in the relevant subject matter areas – example cleaning, CSV, Aseptic, process, CPV, Facility etc.
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