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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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Environmental Monitoring (EM) Sampler will work with the team to perform routine /non-routine Environmental Monitoring (EM Sampling) in GMP areas of Summit West CAR-T Manufacturing and Warehouses. Employee will collect environmental monitoring samples for the controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing.
Shifts Available:
TBD
Responsibilities:
Responsible for performing sample analysis, printing of batch labels, and creating EM sample plans.
Responsible for retrieving sample plates, sanitization of EM equipment and documentation in logbooks.
Responsible for collection of samples per sample plan.
Responsible for delivery of samples to QC Microbiology.
Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by Bristol Myers Squibb (BMS)
Reports any injury or illness immediately and notifies BMS of any hazards, unsafe acts or conditions in the workplace
Performs routine processes following written instructions (SOP’s) in support of the production of pharmaceutical products with adherence to FDA or cGMP guidance
Work in an aseptic production environment
Must be able to wear appropriate clean room attire (i.e. surgical masks, sterile gown) and all Personal Protective Equipment (PPE)
Responsible for accurate completion of all EM Sampling documentation
Operate and maintain equipment and work area to ensure cleanliness and safety following GMPs and SOPs
Ensure that materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs
Contribute to achieving continuous improvement
Must work independently with minimal supervision
Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown
Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory requirements at all times.
Follow directions properly, and work cooperatively as an individual contributor and as a team member.
Communicate effectively with Manufacturing Operations peers, cross-functional peers, and management.
Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
Perform Environmental Monitoring on a routine and non-routine basis for all S12 & S16 GMP manufacturing and associated warehouse areas.
Assist with investigations & CAPAs associated with EM excursions.
Perform all other duties as assigned.
Knowledge & Skills:
Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment
Demonstrates effective written and verbal communication skills
Able to utilize a computer for training
Position requires the ability to wear aseptic gowning (ISO7/ISO8)
Knowledge and understanding of basic math skills to perform calculations
Ability to work independently, within prescribed guidelines, or as a team member
Demonstrates ability to follow detailed directions in a manufacturing cGMP environment
Clear and accurate documentation of all necessary EM sampling information
Thorough understanding of regulatory requirements for cGMP manufacturing facility
Basic Requirements:
Requires a High School diploma or equivalent. Associate or bachelor’s degree in a scientific discipline preferred.
1-2 years of demonstrated work experience in a regulated industry.
Working Conditions
The incumbent will be required to wear a uniform/PPE to work in the manufacturing or laboratory environment.
The incumbent may be required to stand and walk for an extended amount of time.
Start and end times may shift due to needs of production support.
Must be able to perform tasks with hands/arms raised above head for short periods of time
Repetitive hip and upper body twisting movements.
Able to lift 25 pounds on a continuous basis.
The incumbent may be required to work on hazardous materials.
Flexibility with schedule (weekends, holidays, extended hours, and rotating/staggered shifts) is an absolute must.
Flexible to work shift structures.
Position requires the ability to wear aseptic gowning (ISO7/ISO8) for long periods of time.
Change to work timings and assigned tasks may occur at very short notice to support business needs.
Works in production environment with potential exposure to latex and sporicidal agents.
Potential exposure to noise and equipment hazards (i.e., vacuum pumps, pressurized vessels), dangerous materials (i.e. Chemicals, solvents), and strong odors.
Need to be able to read, write and understand English.
This position requires the passing of a pre-employment drug screen in compliance with federal drug testing rules.