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
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:https://careers.bms.com/california-residents/
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