Looking for an experienced Senior Validation Engineer for a global pharmaceutical company in Co. Mayo
You 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.
You will also facilitate the coordination of the Revalidation Schedule on BMRAM, ensuring all activities are completed within the required time-frame.
You 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 the APR schedule and assisting in Audit preparation or responses.
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
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.
You will actively lead validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulator expectations.
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, Aseptics, process, CPV, Facility etc.
If you are interested in this role, please send your resume to firstname.lastname@example.org or call me on 091 455 300 for more information.
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