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Position:  Lyophilization Manufacturing Technician

Location: Manatí, PR

3rd Shift: 10pm-6:30 AM

Rotating Days (Mon-Fry, Sun-Thu, Tue -Sat and Fry – Tues),

Key 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.

a) 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).

b) 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 supports the Parenteral Lyophilization Area and others departments).

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

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

b) Fills, organizes and audit production documentation and maintains Manufacturing Batch Record,

logbooks and other documentation complete.

c) Revises and improve procedures and develops new SOPs based on observations, experiences and

CAPA’s.

d) Reconciles data and prepare computerized documents to provide support to quality investigations or

similar documents as required.

e) 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 utility’s personnel assistance.

a) Handles Hazardous and Non-hazardous waste according to EHS procedures and performs WFI

System loops and tanks sterilization, with utilities personnel assistance.

4. Supports and Participates in the following activities:

a) Participates and assists in resolution of quality investigations.

b) Supports on troubleshooting activities, suggests solutions, and actively participates in problem solving

process.

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

d) Supports Environmental Monitoring Program and Annual Requalification Program.

e) Participates in special projects, during audits and regulatory inspections.

f) Assists in Parenteral Operations validation and qualification activities and in manufacturing activities

in other areas within operations as required.

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

h) Provides support during external, internal, and regulatory audits.

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

Qualifications & 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 other 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

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.

#LI-Onsite

BMSBL

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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