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Note: The job is a remote job and is open to candidates in USA. AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. They are seeking a Senior Validation Engineer/Analyst to lead maintenance, engineering, and validation activities, ensuring product quality meets R&D and Corporate Quality Standards.
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
Skills
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
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k) to eligible employees
Eligible to participate in our short-term incentive programs
Company Overview
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. It was founded in undefined, and is headquartered in Irvine, California, USA, with a workforce of 1001-5000 employees. Its website is
Company H1B Sponsorship
Allergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships, with 1 in 2024, 1 in 2023, 16 in 2022, 14 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.
