Parenteral Manufacturing Technician (R1554648-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
1.Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.
- Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
- Cleans, sanitize, and sterilize manufacturing area rooms and equipments.
- Runs autoclaves to sterilize equipment to be used in the manufacturing process.
- Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
- Performs integrity test of all filters used in the process before and after each use.
- Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
- Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
- Performs sampling of bulk solutions as per batch record requirements.
- Interacts with computer controlled equipment and processes.
- Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
- Verifies calibration status of critical instruments before process operation.
- Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
- Maintains housekeeping within controls and aseptic environments, according to procedures.
- Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves as required. Complete production documentation legible, error free and on time following good documentation practices.
2. Ensures the completeness and compliance of all required documentation during the manufacturing process.
- Maintains inventory and request all necessary components and operating materials.
- Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
- Completes production documentation legible, error free and on time following good documentation practices.
- Audits batch records and documentation, as required.
- Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOP’s before performing the formulation process.
- Revises and improves procedures and develops new SOPs based on observations and experiences.
3. Provides assistance and supports to manufacturing related activities
- Initiates, participates, and assists in resolution of quality investigations.
- Assists in “on the job training” for new employees.
- Participates in special projects and during audits and regulatory inspections as required.
- Participates and assists in area validation and qualification activities.
- Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
- Supports Annual Requalification Program by assuring plan execution on established timeframe.
- Assists manufacturing activities in other areas within operations as required.
- Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision, as requested by supervisor.
4. Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.
- Maintains housekeeping within controls and aseptic environments, according to procedures.
- Handles Hazardous and Non hazardous waste according to EHS procedures.
- Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
- High school diploma with, two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process.
- Knowledge of preparation, formulation and filling processes.
- Basic writing skills when completing area documentation.
- Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
- Ability to work with minimum supervision. • Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
- Knowledge of all critical process parameters and their impact in product quality.
- Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology. .
- Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
- Ability to apply critical thinking to resolve complex issues.
- Excellent leadership characteristics, accountability and commitment.
- Team player and collaborating skills.
- Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
- Skill in performing detailed tasks and documenting information.
- Ability to enter data into a computer and perform complex process transactions.
- Skill in accurate visual inspection (e.g. product and components defects)
- Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.) • Skill in basic mathematical applications.
- Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
- Strong organizational skills
- Able to execute satisfactorily the hands scrubbing and gowning procedures.
- Able to wear sterile gowns, mask, and full face respirators where required.
- Heavy work (25-60 pounds) that requires eye – hand coordination and moving about capacity.
- Requires movements of objects such as lifting, carrying, pushing and pulling. It involves body movements such as handling and fingering.
- This position requires the operators to perform set up and operational activities through gloves in the Isolators. Available to use Full Face Mask, Latex/Nitrile Gloves, and disposable uniforms on a daily basis. Comply with medical surveillance program
- Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.
- Ability to operate pallet jacks.
- Frequent writing and use of keyboard.
- Potential exposure to hazardous chemicals substances during plant work.
- The incumbent must be trained in waste management disposable procedures.
- The use of: hair covers, gloves, coverall suits, respirators, air hoods, ear protection, helmet, etc. for personal and product safety are required accordingly to area that was assigned.
- On a daily basis: 50 -90% standing/walking, 10% sitting
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.