Parenteral Manufacturing Technician

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.

Rotating schedule- horario rotativo

MAJOR DUTIES AND RESPONSIBILITIES      State the most important activities and accountabilities of this position.  Describe how these activities and accountabilities can influence the achievement of departmental or business goals.  (Attach additional sheets if needed):

1. 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.             Percentage of time
• Interacts with automated and computer controlled equipment, ensuring adherence to data integrity principles.

2. 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.

3. 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.

4. 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.

This intent to be a general job description and should not be construed as all inclusive

KNOWLEDGE/ EDUCATION/ EXPERIENCE:     Describe the knowledge, which is required to perform this job in a satisfactory manner.  If this knowledge can be obtained through formal training / education and experience, list the type and amount of education and experience, list the type and amount of education and experience that would typically prepare an individual for this position.

Education & Experience Requirements

• High school diploma or equivalent required.
• Minimum of 2 years of experience in parenteral/aseptic manufacturing, or 3 years of experience in pharmaceutical manufacturing.
• Experience interacting with automated or computer controlled production equipment in a regulated environment preferred.
• Prior exposure to formulation, preparation, or sterile filling operations is strongly preferred.

Technical & Process Knowledge

• Knowledge of preparation, formulation, and aseptic filling processes, including critical process parameters and their impact on product quality.
• Understanding of equipment setup, operation, and teardown following SOPs, with the ability to perform setups consistently and accurately.
• Knowledge of sterilization and contamination control technologies, including steam sterilization, depyrogenation, sterile filtration, lyophilization, and isolator technology.
• Ability to execute filter integrity testing, SIP/CIP processes, and basic troubleshooting of mechanical or process issues.
• Knowledge of cGMP, aseptic technique, environmental control, documentation, EHS, and hygiene practices within a sterile manufacturing environment.

Digital & Systems Skills

• Basic proficiency operating computerized and PLC controlled equipment and following digital workflows.
• Ability to navigate manufacturing systems (HMI, handheld devices, or digital batch record platforms) and perform accurate data entry and system transactions.
• Ability to interpret electronic data, alarms, and system prompts and escalate appropriately.

Behavioral & Work Skills

• Ability to work independently and with minimal supervision, following established procedures and maintaining accuracy in all operational and documentation tasks.
• Strong attention to detail, ensuring precision in manufacturing activities, completion of records in alignment with GDP, and adherence to production schedules and operational priorities.
• Effective communication and collaboration skills, with the ability to work constructively within diverse teams and support cross-functional operations.
• Critical thinking and problem‑solving skills to effectively address process challenges and adapt to evolving operational needs.
• Ability to train peers and new employees, delivering both theoretical and on‑the‑job training.
• Flexibility to work rotating shifts, irregular hours, weekends, and holidays, as required by production demands.
• Demonstrated accountability, reliability, and ownership, upholding high standards for quality, safety, housekeeping, and proper waste handling per procedures and EHS requirements.
• Ability to read and interpret procedures, batch records, and documentation in English and/or Spanish.
• Strong initiative and adaptability to learn new equipment, procedural updates, and emerging technologies.
• Strong organizational and prioritization skills to effectively manage multiple tasks in a fast‑paced manufacturing environment.

MENTAL AND VISUAL DEMAND: Describe the extent to which the job requires close attention to detail, including duration, frequency, and intensity.

• 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.

INITIATIVE AND INGENUITY: Describe the responsibility for taking independent action to perform the job, exercising judgment, or devising new methods and procedures for achieving work goals.  (Indicate frequency also).

1.          Identify and promptly report inconsistencies, atypical conditions, or potential violations of company procedures, quality requirements, or safety policies to supervision.

2.          Plans and organize work activities with a sense of urgency, adjusting priorities to meet operational deadlines in a dynamic and rapidly changing manufacturing environment.

3.          Applies sound judgment to resolve routine operational issues, escalating when appropriate to ensure safe and compliant operations.

4.          Proposes alternatives and evaluates risks and benefits when supporting process decisions, aligning personal and team activities with departmental objectives, business priorities, and BMS values.

PHYSICAL DEMANDS: Describe job requirements, which induce physical fatigue by means of exertion required.  Comment on the frequency and the purpose of activities.

1.          Routine physical activity is required for equipment operation, material handling, and work inside controlled environments. Tasks involve light to moderate manual effort (typically 5–60 lbs), depending on the assignment.

2.          Must be able to perform aseptic gowning and sterile entry procedures, and wear sterile gowns, masks, gloves, and other required PPE when entering classified area and comply with medical surveillance requirements.

3.          Frequent standing and walking (50–90% of the shift), with occasional sitting, bending, reaching, and extended standing during equipment monitoring, loading/unloading, or cleaning activities.

4.          Performs equipment adjustments, handling of tools and components, and manipulation of parts, requiring fine motor skills, hand–eye coordination, and safe body mechanics. Performs setup and operational tasks using glove ports in isolators.

5.          Uses digital interfaces, keyboards, HMIs, and control screens frequently for data entry, equipment monitoring, and GDP compliant documentation.

6.          Must safely lift, carry, push, or pull materials or equipment in the 25–60 lb range as needed, and operate basic material handling equipment such as pallet jacks (occasional use).

7.          May climb stairs or equipment platforms occasionally to access upper-level components.

8.          Must be available to work rotating shifts, irregular hours, weekends, and holidays, depending on operational needs.

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