Senior Engineer, Validation (Temporary Position)

## Company Description **About AbbVie** 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie) ## Job Description 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 - 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 - 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. ***This is a Temporary Position.*** ## 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 t…