Environmental Monitoring (EM) Sampler in Summit, NJ F

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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.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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