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Summary:
Responsible for cleaning, sanitization and decontamination of the Parenteral Manufacturing Areas and equipment in order to support the operations activities according to Good Manufacturing Practices, Safety and Standard Operational Procedures and others policies and controls. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Responsibilities:
Perform daily operation cleaning, sanitization and decontamination of the Parenteral Manufacturing Areas and equipment :
Cleans and sanitizes sterilize manufacturing area rooms and equipments.
Documents the cleaning process following the good documentation practices.
Sterilizes equipment to be used in the cleaning process by operating an autoclave.
Prepares germicide and sporocidal solutions as per SOP.
Filtrates isopropyl alcohol 70%, when necessary.
Maintains inventory and request all necessary components and operating materials in order to assure continue operations.
Completes preparation of cleaning equipment used for production activities.
Maintains good communication with support departments in order to comply with all the manufacturing needs.
Performs fogging process with sporocidal solutions through the Air handling Unit ducts.
Checks and verifies manufacturing equipment, installation, calibration, and connections.
Tests the filter bubble point before and after the IPA filtration process.
Cleans and unloads the autoclave every week.
Completes all required production documentation in a legible, error free and on time manner following good documentation practices.
Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
Coordinates, checks and verifies all manufacturing equipment installation, calibration and connections.
Performs duties related to support other areas as required by the supervisor
Attends and actively participate in meetings and trainings for department communication, safety, security, and quality.
Participates in production scheduling meeting.
Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to the supervisor.
Assists other areas within operations and at the site.
Performs Environmental Health and Safety duties required by the job as follow
Maintains housekeeping within controls and aseptic environments, according to procedures.
Handles Hazardous and Non hazardous waste according to EHS procedures.
Supports Environmental Monitoring Program by assuring sampling collection within manufacturing area on established timeframe.
Supports Annual Requalification Program by assuring plan execution on established timeframe.
Maintains the reusable garment program inventory control.
Knowledge/Skill:
High School Diploma
One (1) year experience in Parenteral or manufacturing processes Knowledge of Aseptic Processing Technical skills.
Understanding of basic science concepts as applicable to the process/product and their impact in product quality.
Proficiency using computer, software, and/or automated equipment as related to assigned functions.
Willing to learn new Computerized, PLC control equipment, procedures and new scientific processes.
Ability to collect numerical data and skill in basic mathematical applications (basic calculations such as additions, subtractions, multiplication, division, rounding, average and yields)
Ability to maintain housekeeping and handles waste according to procedures.
Ability to maintain daily production and labor data in computerized system.
Ability to follows the daily production schedules.
Basic knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization preferable.
Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
Ability to work with minimum supervision, take decisions to resolve day-to-day problems in accordance with regulations and internal procedures.
Ability to communicate via multiple channels and with varied audiences ( team members, FDA, EMEA, OSHA, senior leaders).
Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
Ability to operate pharmaceutical manufacturing equipment.
Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
Knowledge of the basic theory supporting environmental monitoring and in process test and impact of results in product quality.
Understand the impact of temperature, humidity and pressure control and monitoring within an aseptic area. Has knowledge of room classification criteria and specific room’s classification.
Strong organizational skills.
Able to wear sterile gowns, full face mask, and full face respirators where required, use Latex/Nitrile Gloves and disposable uniforms.
Able to move objects such as lifting, carrying, pushing and pulling (25-60 pounds).
Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
Ability to operate pallet jacks
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.
