Sr Validation Engineer

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

 

Job Description

Job Title: Senior Engineer, Validation

Purpose:

The Senior validation engineer function as a lead for the equipment, facility, utilities, and cleaning validation activities.  The incumbent will be primary liaison with the operations, engineering, and third-party vendors for executing activities within the area of responsibility.  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:

 

• 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 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, regarding validation compliance.
• Cultivate and foster strong working relationships with operations, technical and engineering 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 studies/validations and operations. 
• Continually evaluates and balances short-term production support needs with long-term strategic objectives of the department.

Qualifications

Qualifications:

• 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.
• Knowledge/experience in Abbvie engineering and financial systems.
• General understanding of Abbvie Engineering / Validation Standards and Specifications.
• General understanding of pharmaceutical equipment.

Significant Work Activities
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.