Environmental Monitoring Sampler

About the Role

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, transforming 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 in the Cell Therapy Manufacturing Shared Services Environmental Monitoring Operations team. This role is responsible for routine and non-routine Environmental Monitoring (EM Sampling) in GMP areas of Summit West CAR-T Manufacturing and Warehouses.

Responsibilities

• Perform sample analysis, printing of batch labels, and creating EM sample plans.
• Retrieve sample plates, sanitize EM equipment, and document in logbooks.
• Collect samples per the sample plan and deliver them to QC Microbiology.
• Work in compliance with established safe work practices and procedures; use personal protection and safety equipment as required.
• Report any injury, illness, hazards, unsafe acts, or conditions in the workplace.
• Perform routine processes following written instructions (SOPs) in support of pharmaceutical production with adherence to FDA or cGMP guidance.
• Work in an aseptic production environment and wear appropriate cleanroom attire (e.g., surgical masks, sterile gown) and all Personal Protective Equipment (PPE).
• Accurately complete all EM Sampling documentation.
• Operate and maintain equipment and work area to ensure cleanliness and safety following GMPs and SOPs.
• Ensure materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs.
• Contribute to achieving continuous improvement.
• Work independently with minimal supervision.
• 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.
• Follow directions properly and work cooperatively as an individual contributor and as a team member.
• Communicate effectively with peers and management.
• Assist in troubleshooting and solving problems in day-to-day operations.
• Perform Environmental Monitoring on a routine and non-routine basis for all GMP manufacturing and associated warehouse areas.
• Assist with investigations and CAPAs associated with EM excursions.
• Perform all other duties as assigned.
• Flexibility with schedule (weekends, holidays, extended hours, and rotating/staggered shifts) is required.

Requirements

• High School diploma or equivalent.
• 1-2 years of demonstrated work experience in a regulated industry.

Skills

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background including an understanding of biology, chemistry, medical, or clinical practices.

Working Conditions

• Ability to independently don, doff, and wear required PPE (e.g., sterile scrubs, socks, gloves, safety glasses, safety shoes) for extended periods.
• Ability to safely lift, carry, and position portable monitoring equipment (~25 lbs), including transfer on/off carts and through pass-throughs.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals.
• Ability to push and maneuver equipment carts requiring up to 15 lbs of initiation force through corridors and airlocks.
• Ability to perform tasks requiring standing, walking, reaching, and repetitive motions.
• Ability to appropriately respond to alarms, excursions, and equipment malfunctions related to environmental monitoring activities.

Schedule

Sunday - Thursday, Onsite Night Shift, 4 a.m. – 12 p.m.

Pay

Summit West - NJ - US $28.13 - $34.09 per hour. The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs: BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off:
    • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
    • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.