Manager, Project Engineer Equipment Commissioning and Qualification (ECQ) Delivery

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.

At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Project Engineer, Equipment Commissioning & Qualification (ECQ) Delivery, ensures the operation of QC laboratories, commercial manufacturing and support services equipment, utilities and facilities at a multi-product site.

The Project Engineer will be accountable for coordinating multiple projects and ongoing work activities of moderate to high complexity to ensure on-time and within-budget completion. In addition to project coordination, scheduling, and managing project staff, the role also involves spending a small portion of time on individual work.

Shift Available:

• Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.

Responsibilities:

• Leads individual contractors or project teams. Should be able to manage multiple project contractors/project teams simultaneously.
• Conducts interviews with external candidates to fill project positions.
• Provides direction and motivation to project team members.
• Manages the workload of project team members to ensure appropriate work-life balance and track their timesheets.
• Ensures that project team members are appropriately trained for their duties.
• Promotes and ensure the safety of all project team members and adherence to site EHS procedures and guidelines.
• Ensures that project team(s) are in full compliance with local, site, and global BMS policies and procedures.
• Coordinates project execution by effective communication with involved project teams.
• Allocates and manage project resources responsible for performance of Commissioning, Qualification, Validation (CQV) activities of equipment, facilities, utilities and laboratory computerized systems.
• Manages project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
• Oversees the development/review/approval of SOPs, WPs, validation deliverables, plans and policies as needed.
• Ensures resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
• Provides input and guidance for change strategy, risk assessment, testing and compliance gaps.
• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on equipment, utilities, facility and computerized systems qualification and validations issues.
• Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all the members of the ECQ department and site customers while promoting a positive team environment.
• Manages the workload of staff across multiple projects and priorities in the various departments served by the ECQ organization.
• Develops and maintain an effective communication mechanism to keep all affected stakeholders informed about the current status of all systems maintained by ECQ.
• Continuously seeks opportunities to improve internal client satisfaction and strengthen client relationships.
• Ensures equipment, facilities and utilities are maintained in compliance.
• Act as SME in both internal and regulatory audits.

Knowledge & Skills:

• Strong understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems, utilities and equipment.
• Skilled in developing project schedules and implementing project plans.
• Understanding of cost control.
• Ability to train, develop, delegate, and motivate project team members.
• Proven experience with investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi-tasking ability and proven indirect people management skills.
• Ability to effectively manage multiple projects, initiatives, and activities simultaneously.
• Ability to organize and coordinate assigned tasks in a fast-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Excels at meeting objective-oriented schedules and timelines.
• Strong written and verbal communication skills.
• Highly proficient in Microsoft Office Suite.
• Innate ability to learn new software, such as corporate intranet and enterprise business.
• Proficient in computerized maintenance management validation systems (CMMS), validation systems, task-specific software, and systems.
• Ability to create and analyze meaningful metrics, trackers and reports.
• Strong instrumentation background and experience in laboratory and manufacturing operations.
• Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
• Thorough knowledge of cGxP in the pharmaceutical industry.
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

Minimum Requirements:

• BS in Engineering or a science-related discipline. A combination of education and relevant experience will be considered.
• 5 years of experience with equipment qualification.
• 5 years of experience with cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
• Minimum of 4 years of experience managing multiple high priority projects.

Working Conditions:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
• Primarily an office environment. Will be required to enter laboratories or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

BMSCART, #LI-Hybride

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.

Compensation Overview:

Summit West - NJ - US: $106,630 - $129,214


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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.

R1598344 : Manager, Project Engineer Equipment Commissioning and Qualification (ECQ) Delivery