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

Bristol Myers Squibb • Summit, NJ

18h • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager