Senior Engineer, Validation

About the role

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.

Additional information

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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Qualifications & Requirements

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.