Manager, Equipment Commissioning & Qualification

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position

Manager, Equipment Commissioning & Qualification

Reports to

Sr. Manager, ECQ

Location

Warren, New Jersey

PURPOSE AND SCOPE OF POSITION:
The Manager, Equipment Commissioning & Qualification supports the successful operation of facility, laboratory, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role supervises entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures. The individual manages multiple projects and ongoing work activities of low to moderate complexity to ensure on time completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion 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.

DUTIES AND RESPONSIBILITIES:

Management Responsibilities:

Lead a team of up to 10 people. Assist with interviewing internal and / or external personnel to fill necessary roles. Provide direction to internal and external team members. Manage the workload of team members to ensure appropriate work-life balance. Delegate, develop and motivate direct and contract reports. Set goals for and deliver personnel performance reviews for direct reports. Ensure team members are appropriately trained for duties being performed. Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines. Ensure the team is in full compliance with local, site and corporate policies and procedures.
Commissioning and Qualification Activities:
Directly manage Equipment Commissioning & Qualification equipment qualification team. Manage and allocate resources responsible for performing commissioning and qualification of new manufacturing and equipment and/or changes to existing equipment. Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the Systems Lifecycle. Oversee the Development, Review, and Approval of SOPs, work instructions (WIs), plans, test protocols, summary reports, and other commissioning and qualification deliverables. Ensure resources performing validation activities are knowledgeable of applicable procedures and in tune with latest industry regulations and initiatives. Provide input and guidance for change strategy, risk assessments, testing and compliance gaps.
Promoting and providing excellent customer service and support:
Regularly reviews, prioritizes, and promptly responds to customers’ equipment qualification and support requests. Provides technical support and guidance on equipment commissioning and qualification issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Communication and Management of Timelines:

Manages staff workload of multiple projects and priorities across the many different departments that the ECQ organization serves. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment and systems maintained by ECQ to all affected stakeholders. Continually seeks opportunities to increase internal clients’ satisfaction and deepen client relationships.
Regulatory Responsibilities:
Ensures equipment, facilities and programs are maintained in compliance. Acts as departmental lead and SME in both internal and regulatory audits.

REQUIRED COMPETENCIES:

• Knowledge of cGMP, GxP, GAMP, and good documentation practices.
• Knowledge of pharmaceutical manufacturing and laboratory systems and equipment. Cell therapy experience is preferred.
• Advanced working knowledge of the operation and qualification of common equipment (freezers, refrigerators, centrifuges, incubators, tube welders, sealers, balances, etc.)
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Understanding of project scheduling and execution fundamentals.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks / assignments of others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• High proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Working knowledge of scheduling software and systems, and inventory management systems (e.g., BM RAM, Maximo, etc.).
• Ability to create and analyze meaningful metrics.

EDUCATION AND EXPERIENCE:

• BS in Engineering or Science related discipline preferred.
• Minimum of 5 years of experience in FDA-regulated industry.
• Minimum of 3 years of experience managing personnel and/or projects.
• Minimum 2 years of managing direct reports.
• Strong background and experience in laboratory and manufacturing operations.
• Knowledge of cGMP in the pharmaceutical industry.
• Excellent computer skills, including knowledge of inventory, calibration management, and environmental monitoring systems
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Experience interacting with regulatory agents and external and/or internal auditors in a compliance audit environment with direct interaction (including face to face) and responding to audit questions and/or requests.
• Must have strong interpersonal and communication skills, be a team player and be willing and able to work in an environment where individual initiative, accountability to the team, and professional maturity are required

WORKING CONDITIONS:

PHYSICAL /MENTAL DEMANDS:

• 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.

ENVIRONMENTAL CONDITIONS:

• Primarily office environment but will be required to enter laboratory 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.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#LI-Onsite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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