The Senior Validation Engineer functions as the lead for all validation activities and their respective area
of the manufacturing site. 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. All responsibilities should be
executed in a manner to ensure that product quality is maintained at the appropriate level to meet
Corporate Quality Standards/Expectations
•Manage all departmental capital projects and miscellaneous validation 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 compliance to regulatory,
corporate and department requirements.
•Represent department in quality audits, both internal and external, in regards to validation and
•Cultivate and foster strong working relationships with operations and engineering validation
•Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and
•Supervise 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 equipment has the functionality and is
equipped to support new and ongoing manufacturing studies. Responsible for ensuring equipment
reliability expectations are achieved in a high-throughput facility.
•Continually evaluates and balances short term production support needs with long term strategic
objectives of the department