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Position: Parenteral Manufacturing Technician
Location : Manatí PR
** 12 Hrs. Rotational Night Shift; 5:00pm- 5:00 am**
Key Responsibilities 1. Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line
clearance to achieve an efficient operation of the different processes and products yield maximizing.
- Operates and understands the preparation, formulation, and filling equipment functions and basic
troubleshooting activities
- Cleans, sanitize, and sterilize manufacturing area rooms and equipment.
- Runs autoclaves to sterilize equipment to be used in the manufacturing process.
- Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
- Performs integrity test of all filters used in the process before and after each use.
- Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in
the formulation processes.
- Executes the product formulation as per Batch record and Procedure instructions; this includes pH
measurements and adjustments, yield calculations, and volume adjustment.
- Performs sampling of bulk solutions as per batch record requirements.
- Interacts with computer-controlled equipment and processes.
- Monitors critical process parameters and proactively takes necessary action to prevent process deviation
and/or product losses.
Verifies calibration status of critical instruments before process operation.
- Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
- Maintains housekeeping within controls and aseptic environments, according to procedures.
- Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves
as required. Complete production documentation legible, error free and on time following good
documentation practices.
2. Ensures the completeness and compliance of all required documentation during the manufacturing process.
- Maintains inventory and request all necessary components and operating materials.
- Receives, verifies all production records and transaction documents to be error free and in compliance with
established procedures, including computer generated transactions.
- Completes production documentation legible, error free and on time following good documentation
practices.
- Audits batch records and documentation, as required.
- Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or
qualified according to applicable SOP's before performing the formulation process.
- Revises and improves procedures and develops new SOPs based on observations and experiences.
3. Provides assistance and supports to manufacturing related activities
- Initiates, participates, and assists in resolution of quality investigations.
- Assists in on the job training for new employees.
- Participates in special projects and during audits and regulatory inspections as required.
- Participates and assists in area validation and qualification activities.
- Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
- Supports Annual Requalification Program by assuring plan execution on established timeframe.
- Assists manufacturing activities in other areas within operations as required.
- Follows up on progress of activities (e.g. documentation approval) with support departments and inform
status to supervision, as requested by supervisor.
4. Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.
- Maintains housekeeping within controls and aseptic environments, according to procedures.
- Handles Hazardous and Non-hazardous waste according to EHS procedures.
- Attends to all mandatory training meetings for cGMP's, EHS and Company Policies.
Qualifications & Experience
- High school diploma with two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process.
- Knowledge of preparation, formulation, and filling processes.
- Basic writing skills when completing area documentation.
- Basic knowledge on Computerized, PLC control equipment, procedures, and new scientific processes.
- Ability to work with minimum supervision.
- Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
- Knowledge of all critical process parameters and their impact in product quality.
- Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology. .
- Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
- Ability to apply critical thinking to resolve complex issues.
- Excellent leadership characteristics, accountability, and commitment.
- Team player and collaborating skills.
- Knowledgeable in cGMP's, process area, documentation, safety, EHS and hygiene practices.
- Skill in performing detailed tasks and documenting information.
- Ability to enter data into a computer and perform complex process transactions.
- Skill in accurate visual inspection (e.g. product and components defects)
- Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
- Skill in basic mathematical applications.
- Skill in navigating through and performing transactions in mfg computer systems (HMI, handheld computers).
- Strong organizational skills.
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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