Manager, Equipment Commissioning & Qualification (ECQ)

Bristol Myers Squibb; Summit (NJ); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid company holidays

Comprehensive benefits package

Annual company shutdown

Job summary

Bristol Myers Squibb is seeking a Project Engineer/Manager for Equipment Commissioning & Qualification (ECQ) Delivery in Summit, NJ. You will coordinate CQV activities for equipment, facilities, and utilities across a multi-product site, balancing project deadlines with budget constraints.

The role requires strong project leadership, familiarity with cGMP and validation practices, and the ability to manage a team while contributing hands-on as needed.

Qualifications

• BS in Engineering or a science-related discipline; substitution with relevant experience possible.
• Minimum of 7 years of experience in pharmaceutical validation/applications in GMP environments.
• Minimum of 3.5 years of experience managing personnel and/or projects.
• Strong instrumentation background for lab and manufacturing operations.
• Experience with investigations, deviations, and CAPA management.
• Ability to train, develop, delegate and motivate project teams.

Responsibilities

• Leads multiple projects or contractor teams to on-time, within-budget delivery.
• Coordinates project execution and resource allocation for CQV activities.
• Occasionally contributes to hands-on project work.
• Ensures compliance with cGMP, GXP, and 21 CFR Part 11 requirements.
• Maintains effective communication with stakeholders and customers.

Skills

Project management

cGMP knowledge

Interpersonal skills

Communication

Education

BS in Engineering or sciences

Tools

CMMS

Validation systems

GxP software

MS Office

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Description

The Project Engineer/Manager, 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/Manager 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

Mon-Fri: 8AM-5PM

Managerial 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.
• Commissioning and Qualification Activities: Coordinates project execution by effective communication with involved project teams.
• Commissioning and Qualification Activities: Allocates and m/anage project resources responsible for performance of Commissioning, Qualification, Validation (CQV) activities of equipment, facilities, utilities and laboratory computerized systems.
• Commissioning and Qualification Activities: Manages project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
• Commissioning and Qualification Activities: Oversees the development/review/approval of SOPs, WPs, validation deliverables, plans and policies as needed.
• Commissioning and Qualification Activities: Ensures resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
• Commissioning and Qualification Activities: Provides input and guidance for change strategy, risk assessment, testing and compliance gaps.
• Customer Service and Support: Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Customer Service and Support: Provides technical support and guidance on equipment, utilities, facility and computerized systems qualification and validations issues.
• Customer Service and Support: Interfaces with customers to ensure all expectations are being met.
• Customer Service and Support: Maintains a positive relationship with all the members of the ECQ department and site customers while promoting a positive team environment.
• Communication and Management of Timelines: Manages the workload of staff across multiple projects and priorities in the various departments served by the ECQ organization.
• Communication and Management of Timelines: Develops and maintain an effective communication mechanism to keep all affected stakeholders informed about the current status of all systems maintained by ECQ.
• Communication and Management of Timelines: Continuously seeks opportunities to improve internal client satisfaction and strengthen client relationships.
• Regulatory Responsibilities: Ensures equipment, facilities and utilities are maintained in compliance.
• Regulatory Responsibilities: Act as SME in both internal and regulatory audits.
• Specific Knowledge, Skills, Abilities: Strong understanding of cGMP, GXP, GAMP, SDLC regulations, including 21
• Specific Knowledge, Skills, Abilities: CFR part 11, computer systems validation requirements, and good documentation practices.
• Specific Knowledge, Skills, Abilities: Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems, utilities and equipment.
• Specific Knowledge, Skills, Abilities: Skilled in developing project schedules and implementing project plans.
• Specific Knowledge, Skills, Abilities: Understanding of cost control.
• Specific Knowledge, Skills, Abilities: Ability to train, develop, delegate, and motivate project team members.
• Specific Knowledge, Skills, Abilities: Proven experience with investigations, deviations, and CAPA management in a regulated pharmaceutical industry.
• Specific Knowledge, Skills, Abilities: Excellent interpersonal skills with experience dealing with a diverse workforce.
• Specific Knowledge, Skills, Abilities: Strong multi‑tasking ability and proven indirect people management skills.
• Specific Knowledge, Skills, Abilities: Ability to effectively manage multiple projects, initiatives, and activities simultaneously.
• Specific Knowledge, Skills, Abilities: Ability to organize and coordinate assigned tasks in a fast‑paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Specific Knowledge, Skills, Abilities: Excels at meeting objective‑oriented schedules and timelines.
• Specific Knowledge, Skills, Abilities: Strong written and verbal communication skills.
• Specific Knowledge, Skills, Abilities: Highly proficient in Microsoft Office Suite.
• Specific Knowledge, Skills, Abilities: Innate ability to learn new software, such as corporate intranet and enterprise business.
• Specific Knowledge, Skills, Abilities: Proficient in computerized maintenance management validation systems (CMMS), validation systems, task‑specific software, and systems.
• Specific Knowledge, Skills, Abilities: Ability to create and analyze meaningful metrics, trackers and reports.
• Education and Experience: BS in Engineering or a science‑related discipline is preferred but can be substituted with sufficient relevant experience.
• Education and Experience: Minimum of 7 years of experience performing/supporting pharmaceutical application and validation in a GMP environment.
• Education and Experience: Minimum of 3.5 years of experience managing personnel and/or projects.
• Education and Experience: Strong instrumentation background and experience in laboratory and manufacturing operations.
• Education and Experience: 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.
• Education and Experience: Thorough knowledge of cGxP in the pharmaceutical industry
• Education and Experience: Strong problem‑solving skills, strong verbal and written communication skills, and the ability to work independently.
• Education and Experience: 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.
• Working Conditions: Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Working Conditions: Ability to sit, stand, walk and move within workspace for extended periods.
• Working Conditions: Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
• Working Conditions: 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.
• Working Conditions: Ability to work safely and effectively when working alone or working with others.

Compensation Overview

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

The starting pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote‑by‑design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways‑of‑working.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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.

R1608357 : Manager, Equipment Commissioning & Qualification (ECQ)