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[Remote] Senior Engineer, Validation (Temporary Position)
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
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