Specialist, Instrumentation Specialist (Standalone/Process Support Equipment)

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position summary: BMS Cruiserath Biologics seeks to recruit permanent Senior Specialist Instrumentation who will be responsible for maintaining laboratory, standalone and process support equipment in the Manufacturing,  Laboratories and Warehouse/Cryogenics facilities. The Senior Specialist, Instrumentation will report tothe Manager, Standalone & Process Support Equipment Maintenance. A fundamental understanding of instrumentation and equipment qualification is desirable. Experience managing Vendors in a GMP environment extremely beneficial. Knowledge of Biopharmaceutical analytical platforms such as high and ultra performance liquid chromatography would be helpful, but not essential for the role. Key responsibilities will include: · Responsible for the calibration and maintenance program of laboratory/benchtop instruments, CTU’s, standalone assets and process support equipment in the following areas: - MPCC (Multi-product Cell Culture) standalone test equipment/benchtop instruments and process support equipment. - GMP and non-GMP Lab CTU’s (controlled temperature units) - Non-GMP Upstream and Downstream Material Science and Technology Labs as well as Process Analytics lab equipment. - Warehouse and Cryogenics standalone equipment. · Working with Engineering Planners on scheduling and tracking of instrument maintenance and instrument lifecycle management. · Management of Vendors working on site Including management of vendor RAMS (Risk Assessment/Method Statements). · Review and approve documentation associated with analytical instrumentation qualification, calibration, and repairs. · Responsible for work order management/compliance for all assets in scope. · Participate, as part of a team, to deliver on the qualification of new instruments. · Participate in and own internal Investigations and CAPA’s. · Improvement and Optimization of Maximo PM’s/Job Plans and Data Sheets. · Point of contact for projects and change controls associated with equipment in scope. · Participate in troubleshooting of complex instrumentation/equipment issues. · Leading Downtime (DT) and Failure Analysis exercises to ensure re-occurring failures are resolved, with support from other functions. · Ensuring compliance with all Safety and Environmental regulations, and compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management. · Participate in internal and external regulatory audits, as required. · Developing task specific Work Instructions (WI’s) and Risk Assessments (RA’s). Requirements, Qualifications, Knowledge and Skills required include: · The ideal candidate will hold a minimum of a Level 7 qualification in an engineering-related field or a BSc in a scientific discipline, complemented by at least three years of experience in a relevant role within a regulated manufacturing environment. Prior experience with instrument qualification in a GMP laboratory setting is highly desirable. · A mechanical, electrical or