Sr. Engineer 1, Commissioning Qualification and Validation

The Sr CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects. What You’ll Do Supports site readiness, technical transfer (TT), and ongoing manufacturing by configuring and maintaining compliant trending systems, as directed Coordinates with cross-functional teams to deliver projects on time and in full completeness Contributes to building and maintaining routine statistical process control methods and multivariate models for process trending and monitoring Supports ad hoc statistical analysis, as needed Documents process performance and product health through process trending, monitoring, and supporting annual product reviews and manufacturing campaign summary reports Supports technical risk assessments for new manufacturing processes from a process analytics perspective Serves as on-call for process analytics issues and concerns Supports role in Good Manufacturing Practices (GMP) environment Provides technical support for root cause analysis (RCA) and process assessments in response to process deviations, as needed Assists with close out of deviations, as required Supports generation of master batch records (MBRs) and sample plans, as needed Assists site data stewardship activities by ensuring data and analyses are easily findable, accessible, interoperable, and reusable to internal and external stakeholders Supports informatics and data systems improvement initiatives to improve scalability, manufacturability, reliability, yield and cost Supports the curation of critical knowledge related to process analytics systems and multivariate modeling Other duties, as assigned Minimum Requirements Bachelor’s degree in Data Science, Biotechnology, or Chemical Engineering with 5 years of related experience. Preferred Requirements Bachelor’s degree in Engineering. 8 years of experience in validation activities in facilities, commissioning, and systems qualifications. Experience with cGMP or working in another highly regulated industry. Physical And Work Environment Requirements Ability to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of up to 240 minutes. Ability to sit for prolonged periods of up to 240 minutes. Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to operate machinery and/or power tools. Ability to conduct work that includes moving objects up to 50 pounds. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. Will work in warm/cold environments up to 100F Range (mechanical spaces). Will work in outdoor elements such as precipitation and wind. Will work in small and/or enclosed spaces. Will work in heights greater than 4 feet. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr FUJIFILM Biotechnologies