Senior Parenteral Manufacturing Technician

Bristol Myers Squibb•Manatí, PR

3d•$21 - $25•Onsite

About The Position

This position is responsible for various parenteral manufacturing operations, including mechanical and electronic diagnosis and troubleshooting of highly sensitive pharmaceutical/biologics equipment. The role involves both traditional aseptic processing and Isolator Technology. The position requires strict adherence to Security Guidelines, Environmental Health and Safety regulations, SOPs, and current Good Manufacturing Practices.

Requirements

Associate degree in a technical field with seven (7) years of experience in the pharmaceutical field or, Bachelor Degree with five (5) years experience in a Parenteral Manufacturing /Finishing in the Pharmaceutical Industry or Isolation technology.
Basic writing skills when completing area documentation.
Ability to troubleshoot equipment problems and provide resolutions using appropriate problem-solving methodology.
Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes and how to troubleshoot them.
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 on critical process parameters and their impact on 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 and day-to-day situations.
Excellent leadership characteristics, accountability and commitment.
Ability to read, write, comprehend detailed technical information and directions and read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.).
Team player and collaborating skills.
Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
Functional and basic technical knowledge of complex and automated equipment (computer, or PLC control) for set-up, operation and troubleshoot using the interface systems.
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).
Skill in basic mathematical applications.
Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
Ability to relate and convert from metric (S.I.) to/from English units.
Ability to plan and/or follows work schedules, set priorities.
Strong organizational skills.
Able to wear sterile gowns, mask, and full face respirators and able to use Full Face Mask, Latex/Nitrile Gloves, and disposable uniforms on a daily basis.
Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
Ability to operate pallet jacks.

Responsibilities

Perform mechanical evaluation and troubleshooting of manufacturing equipment failures.
Perform initial evaluation and minor troubleshooting diagnosis of manufacturing equipment failures.
Support maintenance personnel in major troubleshooting diagnosis activities.
Perform complex and highly technical manufacturing operations including Diafiltration and Concentration of Proteins, Formulation of Proteins, Filling of Proteins in syringes and Vials within Isolators / Barrier Systems or in aseptic area process, Lyophilization process with Automatic Loading within Isolators / Barrier Systems or loading Lyophilizers on aseptic environment, Clean in Place (CIP) and Steam in Place (SIP) process in different systems, Decontamination of Isolator/ Barrier System with Vapor Hydrogen Peroxide (VHP), Sterilization cycles with Steam Autoclaves and Dry Heat Ovens and Tunnels, Isolators and gloves leak test.
Operate manufacturing processes efficiently to maximize product yield.
Monitor critical process parameters and proactively take necessary action to prevent process deviation and/or product losses.
Maintain housekeeping within controls and aseptic environments according to procedures.
Handle Hazardous and Non-hazardous waste according to EHS procedures.
Receive, verify, and maintain all production records and transaction documents error-free and in compliance with established procedures, including computer-generated transactions.
Receive, handle, verify, and weigh excipients, drug substances, and/or active ingredients.
Perform systems integrity tests such as isolators, ultra filtration skid, distribution systems, filters, and gloves as required.
Verify calibration status of critical instruments before process operation.
Complete production documentation legibly, error-free, and on time, following good documentation practices.
Assist manufacturing activities in other areas within operations as required.
Initiate, participate, and assist in the resolution of quality investigations.
Audit batch records and documentation as required.
Revise and improve procedures and develop new SOPs based on observations and experiences.
Participate in special projects, during audits, and regulatory inspections as required.
Participate and assist in area validation and qualification activities.
Support the Annual Requalification Program by assuring plan execution within the established timeframe.
Attend all mandatory training meetings for cGMP’s, EHS, and Company Policies.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
11 paid national holidays
Unlimited paid sick time
Up to 2 paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day.