Engineer Commissioning, Qualification & Validation (CQV)

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:

Reporting to the Senior Manager, or designee, the CQV Engineer performs duties required to support validation activities for Leiden Cell Therapy Facility and ensures protocols and reports are in compliance with BMS requirements. This member will be responsible for executing and coordinating Installation, Operational and Performance qualification (IQ/OQ/PQ) activities when required.

Responsibilities:

- Write protocols, perform field executions, and create final reports for Analytical Instruments/Equipment/utilities/facilities system qualifications.

- Communicate progress effectively.

- Ensure process and project documentation is accurate and updated.

- Maintain safe working environment.

- Follow company policies and procedures.

- Ensure accuracy of data presented in protocols and reports.

- Ensure data is recorded / reviewed using good documentation practices (GDP).

- Ensure calibration of equipment used for validation activities is up to date.

- Interfaces with customers to ensure all expectations are being met.

- Works collaboratively with Manufacturing, Technical Manufacturing, Manufacturing Technology, Facilities & Engineering and Quality.

- Coordinate and communicate with area owners to ensure completion of requalification and qualification activities.

- Perform requalification/revalidation activities as necessary.

- Ensure process and project documentation is accurate and updated.

- Provide input to Validation Services department SOPs review activities.

- Engage in and contribute to continuous improvement projects.

Qualifications:

- BS in Engineering or Science related discipline preferred with a minimum of 1-3 years’ experience performing and/or supporting pharmaceutical application validation in a GMP environment.

- Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and good documentation practices.

- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

- Experience or close familiarity with analytical instruments/equipment/utility/facility qualifications and general commissioning, qualification and validation practices are desired.

- Experience collaborating with multi-functional teams.

- Excellent communication and technical writing skills are required.

- No travel requirements.

#LI-Hybrid

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604115 : Engineer Commissioning, Qualification & Validation (CQV)