The Senior Validation Engineer functions as the lead for all maintenance, engineering, and validation activities within the clinical packaging area. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent will be the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. The incumbent will also be responsible for the management of the area Engineering Technician. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations.
Responsibilities
- Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
- Manage all equipment, facility, utility and cleaning validation activities.
- Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
- Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
Interface with area managers from the Operations and Quality functions through the Validation Review Boards. - Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
- Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements. - Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
- Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
- Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
- Supervise FTE engineering technicians and contract validation engineering as needed. Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
- Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies. Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
- Continually evaluates and balances short term production support needs with long term strategic objectives of the department.
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