PARENTERAL MANUFACTURING TECHNICIAN

Bristol-Myers Squibb Co; Manatí (PR); Vor Ort; USD 22.000 - 28.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb Co in Manatí, PR seeks a Parenteral Manufacturing Technician to perform setup, operation, and cleaning of parenteral manufacturing equipment, ensuring compliant production. You will handle formulation steps, sampling, and data integrity across automated systems.

This role requires strict adherence to GDP and aseptic techniques. The position includes rotating shifts and comprehensive benefits, with pay ranging hourly in the local market.

Qualifikationen

• Performs routine and critical operational activities required for the setup, operation, and cleaning of parenteral manufacturing equipment to ensure consistent, efficient, and compliant production processes.
• Conducts equipment setup, changeover, cleaning, and line clearance following approved SOPs and safety procedures.
• Operates formulation, preparation, and filling equipment; performs basic troubleshooting and escalates abnormalities.
• Cleans, sanitizes, and sterilizes classified manufacturing areas and equipment in compliance with aseptic and contamination‑control standards.
• Operates autoclaves and executes sterilization cycles for manufacturing components and equipment.
• Performs Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations for tanks and systems.
• Executes pre‑ and post‑use filter integrity testing.
• Receives, verifies, handles, and weighs excipients and drug substances/active ingredients for formulation steps.
• Executes formulation processes per batch record instructions, including pH adjustment, yield calculations, mixing parameters, in‑process controls, and volume adjustments.
• Collects required in‑process samples following aseptic sampling techniques.
• Interacts with automated and computer‑controlled equipment, ensuring adherence to data integrity principles.

Aufgaben

• Performs routine and critical operational activities required for the setup, operation, and cleaning of parenteral manufacturing equipment to ensure consistent, efficient, and compliant production processes.
• Conducts equipment setup, changeover, cleaning, and line clearance following approved SOPs and safety procedures.
• Operates formulation, preparation, and filling equipment; performs basic troubleshooting and escalates abnormalities.
• Cleans, sanitizes, and sterilizes classified manufacturing areas and equipment in compliance with aseptic and contamination‑control standards.
• Operates autoclaves and executes sterilization cycles for manufacturing components and equipment.
• Performs Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations for tanks and systems.
• Executes pre‑ and post‑use filter integrity testing.
• Receives, verifies, handles, and weighs excipients and drug substances/active ingredients for formulation steps.
• Executes formulation processes per batch record instructions, including pH adjustment, yield calculations, mixing parameters, in‑process controls, and volume adjustments.
• Collects required in‑process samples following aseptic sampling techniques.
• Interacts with automated and computer‑controlled equipment, ensuring adherence to data integrity principles.

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Schedule-5pm-5am- rotating days- dias rotativos

Execute Parenteral Manufacturing Operations

Performs routine and critical operational activities required for the setup, operation, and cleaning of parenteral manufacturing equipment to ensure consistent, efficient, and compliant production processes.

• Conducts equipment setup, changeover, cleaning, and line clearance following approved SOPs and safety procedures.
• Operates formulation, preparation, and filling equipment; performs basic troubleshooting and escalates abnormalities.
• Cleans, sanitizes, and sterilizes classified manufacturing areas and equipment in compliance with aseptic and contamination‑control standards.
• Operates autoclaves and executes sterilization cycles for manufacturing components and equipment.
• Performs Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations for tanks and systems.
• Executes pre‑ and post‑use filter integrity testing.
• Receives, verifies, handles, and weighs excipients and drug substances/active ingredients for formulation steps.
• Executes formulation processes per batch record instructions, including pH adjustment, yield calculations, mixing parameters, in‑process controls, and volume adjustments.
• Collects required in‑process samples following aseptic sampling techniques.
• Interacts with automated and computer‑controlled equipment, ensuring adherence to data integrity principles.

Documentation, Compliance, and Process Control

Execute Parenteral Manufacturing Operations

Performs routine and critical operational activities required for the setup, operation, and cleaning of parenteral manufacturing equipment to ensure consistent, efficient, and compliant production processes.

• Conducts equipment setup, changeover, cleaning, and line clearance following approved SOPs and safety procedures.
• Operates formulation, preparation, and filling equipment; performs basic troubleshooting and escalates abnormalities.
• Cleans, sanitizes, and sterilizes classified manufacturing areas and equipment in compliance with aseptic and contamination‑control standards.
• Operates autoclaves and executes sterilization cycles for manufacturing components and equipment.
• Performs Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations for tanks and systems.
• Executes pre‑ and post‑use filter integrity testing.
• Receives, verifies, handles, and weighs excipients and drug substances/active ingredients for formulation steps.
• Executes formulation processes per batch record instructions, including pH adjustment, yield calculations, mixing parameters, in‑process controls, and volume adjustments.
• Collects required in‑process samples following aseptic sampling techniques.
• Interacts with automated and computer‑controlled equipment, ensuring adherence to data integrity principles.

Documentation, Compliance, and Process Control

Ensures complete, accurate, and compliant execution of batch records and associated documentation, supporting data integrity and audit readiness across all operations.

• Maintains accurate inventory of components and materials; submits timely requests to support uninterrupted operations.
• Completes all production records and system transactions accurately, legibly, and in real‑time following Good Documentation Practices (GDP).
• Verifies accuracy and completeness of manufacturing documentation, including computer‑generated transactions.
• Performs batch record audits, as required.
• Ensures assigned equipment is cleaned, labeled, calibrated, and qualified before use.
• Identifies opportunities to improve procedures and contributes to the development or revision of SOPs.

Support Manufacturing and Cross‑Functional Activities

Provides support to quality, validation, operational, and training activities that ensure efficient and compliant manufacturing.

• Initiates and participates in quality investigations, providing technical input and timely documentation.
• Supports onboarding and “on‑the‑job” training of new employees.
• Participates in internal, external, and regulatory inspections.
• Supports validation and qualification activities within the manufacturing area.
• Ensures timely execution of Environmental Monitoring sampling responsibilities.
• Supports annual requalification programs and area readiness activities.
• Provides assistance to other manufacturing areas as operational needs arise.
• Communicates status of documentation, activities, and pending actions to supervision and partner departments.

Ensure Safety, Environmental, and GMP Compliance

Executes all activities with a strong focus on employee safety, environmental protection, contamination control, and compliance with cGMP standards.

• Maintains housekeeping and aseptic conditions within controlled environments in alignment with contamination‑control practices.
• Handles hazardous and non‑hazardous waste according to Environmental, Health & Safety (EHS) procedures.
• Completes required training for cGMP, EHS, aseptic practices, and company policies.
• Actively identifies and reports safety risks, participating in initiatives to promote a safe and compliant work environment.

• Requires steady attention to detail during routine manufacturing tasks such as equipment setup, monitoring processes, and completing documentation.
• Must maintain awareness of process conditions, noticing alarms, unusual readings, or equipment irregularities and escalating them promptly.
• Requires regular use of digital systems and control screens, needing accurate visual checks and basic interpretation of displayed information.
• Must stay focused during repetitive tasks and when working inside controlled areas or around production equipment.
• Requires the ability to remain calm and attentive when unexpected situations arise, such as abnormal process conditions or minor deviations.
• Identify and promptly report inconsistencies, atypical conditions, or potential violations of company procedures, quality requirements, or safety policies to supervision.
• Plans and organize work activities with a sense of urgency, adjusting priorities to meet operational deadlines in a dynamic and rapidly changing manufacturing environment.
• Applies sound judgment to resolve routine operational issues, escalating when appropriate to ensure safe and compliant operations.
• Proposes alternatives and evaluates risks and benefits when supporting process decisions, aligning personal and team activities with departmental objectives, business priorities, and BMS values.

#BMSBL

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Manati - PR - US: $16.70 - $20.24per hour

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606231 : PARENTERAL MANUFACTURING TECHNICIAN