AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Senior Validation Engineer/Analyst functions as the lead for  maintenance, engineering, and validation activities within the assigned site/area of responsibility. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent is 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 R&D and Corporate Quality Standards/Expectations.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Manage departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
• Manage 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.
• 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 regard to validation and engineering compliance.
• Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
• Partners with all levels of key business functions to ensure equipment has functionality and is equipped to support new and ongoing clinical studies.
• Conform to EH&S management system requirements and compliance obligations, promote continuous improvement and consider EH&S aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal and any program applicable according to the position duties.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s Degree, a BS in engineering is preferred, or related science discipline.
• 6+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
• Knowledge/experience in creating and executing validation documents in Documents Management System (DMS).
• General understanding pharmaceutical and/or Bio-Pharm Industry Engineering Standards and Specifications.
• General understanding of pharmaceutical packaging equipment, Drug Products and BDS equipment.

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. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html