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Position: Manufacturing Technician Lyofilization

Location: Manati- PR

To perform all the activities related to the Lyophilization processes for the parenteral manufacturing operations (Par Lyo & Parenteral Vials /PVA). In addition the incumbent monitors and performs activities related with the Environmental Control System and the Water for Injection System (WFI) with others departments. This position must comply with all Security guidelines, Environmental Health and safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES:

1. Performs daily monitoring and operation of Parenteral Lyophilization manufacturing equipment in addition, coordinates, checks and verifies, calibration and, reports any equipment malfunctions to the production and maintenance supervisor.

• Operates and monitors computerized systems Freeze Dryers (this include but is not limited to Filter Integrity tests, Clean in Place (CIP), Sterilization in Place (SIP), and Leak Tests (Vacuum Leak Rate and Bellows Tests).

• Monitors Par Lyo and PVA areas environmental conditions (such as temperature, humidity and differential pressure) and; the utilities systems (such as Water for Injection (WFI) and the steam generator that support the Parenteral Lyophilization Area and others departments).

2. Ensures that area documentation is complete following good documentation practices:

• Initiates work orders, document revision, quality events, SAP transactions, etc.

• Fills, organizes and audit production documentation and maintains Manufacturing Batch Record, logbooks and other documentation complete.

• Revises and improve procedures and develops new SOPs based on observations, experiences and CAPA’s.

• Reconciles data and prepare computerized documents to provide support to quality investigations or similar documents as required.

• Follows up progress of activities (e.g. documentation approval) with the support departments and inform status to supervision as requested.

3. Maintains housekeeping within controls and aseptic environments, according to procedures and Handles area Hazardous and Non-hazardous waste according to EHS procedures. Also performs WFI System loops and tanks sanitization, with the utilities personnel assistance.

4. Supports and Participates in the following activities:

Participates, and assists in resolution of quality investigations.

• Supports on troubleshooting activities, suggests solutions and actively participates in problem solving process.

• Monitors formulation process in the PAS (Process Automation System) as required.

• Supports Environmental Monitoring Program and Annual Requalification Program.

• Participates in special projects, during audits and regulatory inspections.

• Assists in Parenteral Operations validation and qualification activities and in manufacturing activities in other areas within operations as required.

• Assists in “on the job training” for new employees.

• Provides support during external, internal and regulatory audits.

5. Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.

KNOWLEDGE/ EDUCATION/ EXPERIENCE:

• High School diploma with Five (5) years of experience in a Pharmaceutical industry including two (2) years of experience in Lyophilization process or Technical Degree in Refrigeration, Electronic or Instrumentation with One (1) year of experience in a Pharmaceutical industry including at least one (1) year of experience in Lyophilization processes and /or biotechnology processes.

• Ability to reconciles and interprets data from Lyophilization cycles, and provide support for quality investigations related with cycles.

• Ability to generate additional area process reports requested by internal and/or external customers. Develop and maintain area performance metrics.

• Ability to troubleshoot area problems and generate Work orders

• Willing to learn new equipment procedures and processes and train others operators.

• Ability to maintain housekeeping and handles waste according to procedures. Revise current procedures and develop new SOP’s.

• Ability to provide job training (theoretical and/or On the Job) for new employees following the Parenteral Operations Department Qualification Curriculum.

• Ability to maintain daily production and labor data in computerized system.

• Ability to follows the daily production schedules.

• Willing to work irregular hours, rotative shifts, weekends and holidays when necessary

PHYSICAL DEMANDS:

1. Adjust controls and equipment. Clean work area.

2. Climb stairs and ladders.

3. Connect cables and plugs.

4. Typical working conditions: 50 – 90% standing/walking, 10% sitting

5. Open doors and boxes.

6. Sort product and materials.

7. Use keyboard and computer or terminal to enter data.

8. Able to execute satisfactorily the hands scrubbing and gowning procedures.

9. Able to wear sterile gowns and mask while working inside the Aseptic Area.

10. Heavy work (25-60 pounds) that requires eye – hand coordination and moving about capacity.

11. Requires movements of objects such as lifting, carrying, pushing and pulling. It involves body movements such as handling and fingering.

12. Ability to operate pallet jacks.

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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

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

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