Parenteral Manufacturing Technician

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. 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 cro