Cell Therapy Global Equipment Qualification Engineer I or II
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
PURPOSE AND SCOPE OF POSITION:
The Global Equipment Qualification Engineer is responsible for the strategic alignment across multiple clinical and commercial Cell Therapy sites with respect to equipment, facility, and utility qualification. Additionally, this role will oversee Contract Manufacturing sites to ensure compliance and alignment with BMS requirements. Applies project management as well as engineering skills to ensure projects are successful, on-time, and effectively completed across multiple sites (where applicable).
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Bachelor’s Degree in Engineering required (Chemical, Biochemical or Mechanical Engineering is preferred).
- 2+ years of Equipment Qualification experience in a healthcare related industry (Biologics, Medical Device, Computer Science, Pharmaceutical preferred).
- Experience/familiarity with computer and/or software qualification
- Experience with regulations as applicable to equipment qualification
- Experience with hands on equipment qualification for example but not limited to development of user requirements, as well as development and execution of validation/qualification protocols
- Experience working with external parties and/or leading cross-functional teams is required.
Knowledge, Skills, and Abilities
- Knowledge of facility/clean room classifications preferred
- Experience and knowledge of cGMP’s, GDP’s, and Data Integrity is required.
- Strong verbal/written communication skills and ability to influence at all levels is required.
- Ability to think strategically and to translate strategy into actions.
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment.
DUTIES AND RESPONSIBILITIES:
- Involvement (Either leading or supporting) with all activities related to the strategy and approach for equipment, facility and utility qualification.
- Leads activities to determine requirements for new equipment and technology
- Provides support to site teams on the implementation of new technology across multiple sites.
- Provides guidance across all internal as well as external sites on the equipment, facilities, and utilities utilized in the manufacturing of commercial and clinical products.
- Work with development teams as well as applicable site teams to trouble shoot issues that may arise with regards to equipment/facilities/utilities.
- Optimize strategies across sites to ensure not only alignment but efficient process with regards to both hardware as well as software (stand-alone) validation activities.
- Support the development of site master plans, project plans, tech transfer plans as applicable
- Support site activities as required to ensure timelines are met as well as ensuring compliant and robust testing strategies with respect to equipment/facility/utility qualification.
- Ensure safe and compliant cGMP operations.
- Stay current with industry trends and standards and participate in best practice forums consistent with function responsibilities.
- Foster strong inter-team relationships to achieve common project goals.
- Support management in accomplishing productivity and financial goals with the cross-functional team.
- Create an environment of teamwork, open communication, and a sense of urgency.
- Support the change agent in promoting flexibility, creativity, and accountability.
- Support organizational strategic goals and objectives that are linked to the overall company strategy.
- Drive strong collaboration within the plant and across the network.
- Build trust and effective relationships with peers, stakeholders, and external suppliers.
- Deliver business results through timely and quality decision making and advice.
- Foster a culture of compliance and strong environmental, health, and safety performance.
- Promote a mindset of continuous improvement, problem solving, and prevention.
The starting compensation for this job is a range from $65,000 - $82,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.
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 firstname.lastname@example.org. 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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