Sr. Specialist, Associate Scientist

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.

The Site Validation Services Group is responsible for Installation, Operational and Performance Qualification (IQ/OQ/PQ) of process equipment, support in-process analytical equipment, validation of SIP processes and validation of critical process utility systems. Responsibilities include validation work arising from change controls, capital projects, continuous improvement, shutdown/changeover activity, and ongoing revalidation programs. The primary responsibility of this Sr. Specialist, Associate Scientist position is to support the qualification needs for BMS Validation life cycle.

Duties/Responsibilities:

• Write protocols, perform field executions, and create final reports for Equipment/utilities/facilities system qualifications

• Perform Mapping studies for control temperature units (CTUs) equipment, warehouse, autoclaves and steaming of process equipment.

• Ensure calibration of equipment used for validation activities is up to date.
• Support execution of additional studies such as smoke studies, periodic assessments.
• Coordinate and communicates with area owner to ensure completion of requalification and qualification activities.
• Writes protocols, perform field executions, and create final reports for requalification/revalidation activities; among the activities required are the following but not limited to: Prepare equipment to execute protocols; Record/review data using good documentation practices; Obtain samples and submits to the appropriate testing laboratory when required; Notify to management of any discrepancy and conduct investigation as required.
• Provide input to Validation Services department SOPs review activities.
• Support validation department activities to maintain proper documentation storage and database system.
• Communicate progress effectively
• Ensure process and project documentation is accurate and updated
• Maintain safe working environment
• Follow company policies and procedures
• Maintain familiarity with BMS directives and industry guidelines on validation.

Qualifications:

Direct experience or close familiarity with IQ/OQ/PQ of critical utilities validation (e.g. Pure Steam, WFI, Compressed Gases), and temperature mapping concepts is required (e.g. SIP, Autoclave, Freezer, Incubator, Warehouse, Cold Rooms). Experience supporting and maintaining Validation Requalification Program. Role requires in depth working knowledge of current FDA Aseptic Process Guidance for Industry, solid background and experience with GMP’s, and hands-on experience with USP, EP and JP. Experience improving and maintaining equipment, excellent project management, communication, and technical writing skills are also required. The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

Education/Experience/ Licenses/Certifications:

B.Sc, B.Eng in Biology, Chemistry or Chemical/Biochemical Engineering with a minimum of 1-3 years relevant experience or a M. Sc in Biology, Chemistry or Chemical/Biochemical Engineering with 0-2 years relevant experience . Associates Degree with 4-6 years with relevant experience will be considered.

Physical Demands

Infrequent repetitive use of hands and wrist, infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting and stopping to allow for gowning into classified environment. Requires the use of manufacturing personal protective equipment.

Work Environment

The work involves inside work. Work will take part both individually and as part of a group atmosphere. The work could take place in a classified GMP area as well as an office environment.

Travel

This position requires up to 0 % of travel

Supervisory Responsibilities

No supervision of personnel

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.

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