Senior Quality Engineer, Validation

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

Responsibilities:

•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

engineering compliance.

•Cultivate and foster strong working relationships with operations and engineering validation

disciplines.

•Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and

operations processes.

•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

•Bachelor’s Degree, a BS in an engineering or science discipline. •5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area. •Knowledge/experience in creating and executing validation documents. •Knowledge/experience in Abbvie engineering or science systems. •General understanding of Abbvie Engineering Standards and Specifications. •General understanding of pharmaceutical equipment