Job Description

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 Summary

The position is responsible for the design, installation, start-up, and qualification of equipment used in the manufacturing process for Biologics products.  The new equipment can be broken down into four primary areas – Vial Line w/Isolator, Syringe Line w/Isolator, Freeze Dryers, and Formulation Equipment/Component Prep.  Each engineering position will be responsible for one of the four primary areas listed above.  After the equipment is designed, fabricated, installed, and started-up, the position will transfer to a Process Engineering role and will be involved in qualification of the equipment and to provide technical support of the equipment, from a process perspective.

The position will be responsible for managing all aspects of their assigned equipment including initial design, User Requirement Specification adherence, vendor management and coordination, assurance of compliance with BMS standards, functionality, integration of the equipment with other equipment/systems, line/system controls & automation and coordination with all associated stakeholders.

The position will have responsibilities during the design and fabrication of the equipment which will include technical assessments to assure the equipment is capable of operating at the specified rates and adhering to the established quality attributes and safety attributes.  Other responsibilities include taking a lead role in Factory Acceptance Tests, site installations, Site Acceptance testing and qualification to assurance the equipment is designed for effective functionality and maintainability.

Other responsibilities include life cycle activities including PM development, general technical support of ongoing equipment issues, sustainability considerations, and support to the Maintenance department related to operational issues of the equipment.

Required Competencies:  Knowledge, Skills, and Abilities

• Advanced knowledge of aseptic filling line technology w/isolators, freeze dryers, formulation equipment, and prep equipment such as autoclaves, parts washers, single use technologies.
• Advanced knowledge of equipment control systems.
• Advanced knowledge of plant equipment including utilities, HVAC, and facilities.
• Strong relationship skills, including the ability to lead/influence people outside of your direct authority.
• Advanced knowledge of Project Management principles.
• Advanced knowledge of cGMP, GAMP, and OSHA regulations.
• Advanced knowledge of regulatory requirements.
• Advanced written and verbal communication skills.
• Ability to interpret/write complex business documents.
• Strong people skills required to work effectively with and support diverse personality types.
• Ability to develop, delegate, and motivate others.
• Advanced presentation development and delivery skills.
• Advanced critical reasoning and decision-making skills.
• Ability to facilitate a teamwork environment, delegate appropriately, and motivate others.
• Ability to think strategically and be flexible in order to achieve long range objectives.
• Advanced knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.
• Advanced knowledge of quality control systems, engineering, aseptic design and philosophy.

Key Responsibilities

• Responsible for all technical aspects of pharmaceutical processing equipment to be installed and qualified in the Phoenix manufacturing facility.
• Responsible for the design, installation, start-up, and qualification of pharmaceutical processing equipment.
• After the equipment is installed and qualified for manufacturing use, the position is responsible for the establishment of PMs as well as work with Maintenance to assure the equipment is properly maintained.
• Work with Manufacturing on any operational issues or improvements needed as the equipment is put in operation.
• Support Maintenance in troubleshooting any related operational issues.

Qualifications & Experience

• Bachelor’s degree in an engineering field or other science related field preferred.
• 7 years of relevant work experience required, preferably in a pharmaceutical or engineering environment.
• An equivalent combination of education, experience, and training may substitute.
• Advanced knowledge of Aseptic processing equipment.
• Advanced knowledge of mechanical, utility, manufacturing, and other plant systems.
• Advanced knowledge of quality control systems, cGMP engineering design practices, equipment installation techniques including sustainability opportunities, OSHA regulations, and Factory Mutual requirements.
• Demonstrated skills at solving challenging project issues with the ability to develop creative solutions.
• Demonstrated project leadership skills and effective decision-making abilities throughout a project while including key stakeholders.

*Must be open to international EU travel 30% annually

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.