Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
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 Validation Associate Scientist/Engineer I position is to support the qualification needs for equipment/facilities/utilities validation, including Sterilization-In-Place (SIP), initial qualification and support maintenance of qualified state as part of BMS Validation life cycle.
Author, review, and execute protocols for general validation activities as required and final reports. Author, review, and execute development studies protocols and final reports.
Author, review and execute investigation reports.
Identify opportunities for process improvements, present formal recommendations and drive improvements to completion.
Identify and assist with implementation of new technologies/procedures for Validation.
Review standard operating procedures (SOP), and other cGMP documentation as required.
Provide support and/or maintain requalification schedule adherence and ensure work is executed "right first time" in order to reduce equipment down time.
Maintain familiarity with BMS directives and industry guidelines on validation.
Direct experience or close familiarity with critical utilities validation (e.g. Pure Steam, WFI, Compressed Gases), and temperature mapping concepts (e.g. SIP, Autoclave, Freezer, Refrigerator, Incubator, Warehouse, Cold Rooms) is a must. 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.
B.Sc, B.Eng in Biology, Chemistry or Chemical/Biochemical Engineering with a minimum of 1-3 years direct experience or a M. Sc in Biology, Chemistry or Chemical/Biochemical Engineering with 0-2 years direct experience . Associates Degree with 4-6 years with direct experience will be considered. Bachelors preferred.
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.
The work involves inside work. Work will take part of 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.
Minimal travel is anticipated for this role.
No supervision of personnel
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 the resources to pursue their goals, both at work and in their personal lives.