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.

Title: Senior Specialist, Equipment Commissioning & Qualification

Location: Warren, NJ

The C&Q Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities projects and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures.

Key Responsibilities

• Author, review, approve, and execute test protocols, plans, summary reports, protocol deviations, and other validation deliverables as required.
• Administer change control activities and corrective and preventive actions.
• Author, review, and approve SOPs, work practices, and other procedural documents.
• Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
• Serve as a Subject Matter Expert for change controls, investigations, CAPAs, and deviations as applicable.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met.
• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
• Ensures timely completion of facilities, utilities, and equipment commissioning and qualification projects, individually and/or with support of colleagues.
• Develops an effective mechanism for communicating the current status of all ECQ projects to affected stakeholders.
• Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
• Ensures manufacturing and laboratory equipment, facilities, and utilities are maintained in compliance with GMP and other BMS standards and regulations.
• Acts as equipment, facilities, and utilities commissioning and qualification Subject Matter Expert in internal and regulatory audits.

Qualifications & Experience:

• BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs.
• Minimum of 6 years of experience in FDA-regulated industry.
• Minimum of 4 years of experience developing and executing facility and utility qualifications.

• Advanced knowledge of cGMP pertaining to pharmaceutical facilities, utilities, and equipment.
• Strong background and experience in laboratory and manufacturing operations with advanced knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
• Advanced knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.
• Excellent technical writing skills and proficiency with Microsoft Suite and Word formatting functions; detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
• Excellent interpersonal/communication skills and experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Independently and effectively manage multiple tasks and activities simultaneously.
• Working knowledge of scheduling software and systems, and inventory management systems.
• Ability to create and analyze meaningful metrics.
• Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred.
• Preferred experience commissioning and qualifying liquid nitrogen supply systems, DI Water, autoclaves, isolators, and filling and capping equipment.
• Strongly preferred experience designing and performing airflow visualization studies and executing temperature/humidity mapping qualifications for controlled storage areas.

#LI-Onsite

BMSCART

VETERAN

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 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.

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/

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