Manager, QC Instrument Lifecycle Engineer

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 rich in diversity. 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.

Responsibilities include (but not limited to):

• Act as the project lead/project manager for assignments related to the qualification of QC equipment and its associated software
• Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary report
• Author/execute computer system validation scripts
• Own change controls specific to the qualification of QC instruments and its associated software
• Update the asset management database to reflect new assets, calibrations, preventative maintenances
• Generate/execute Continuous Improvement (CI) initiatives
• Author instrument operational SOPs as needed
• Coordinate/interface/host vendors on site
• Champions deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs)
• Acts as the liaison between Digital Plant (IT) and lab departments
• Completes decommissioning/periodic assessments
• Anticipates and performs complex troubleshooting and problem solving independently.
• May represent the department in regulatory inspections (internal and external audits).

Education, Qualifications and Experience Required:

• Bachelor’s degree in relevant scientific, engineering, or computer-based area with 6 – 10+ years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
• Quality management system experience including document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
• Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
• Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
• Demonstrated success in cross functional influencing, strong communication, and collaboration skills
• Working knowledge of Microsoft Office applications, preferred.
• Must have equipment validation experience
• Must have GMP experience
• Must have Quality Management System (QMS) experience
• Experience in Computer System Validation is a plus.
• Experience in any asset management software is a plus.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol