Senior Parenteral Manufacturing Technician
Bristol-Myers Squibb
- Location
- Manati - PR - US
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 57 approvals (FY2023)
- Posted
- 22h ago
About this role
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 . Shift D (5pm to 530am) PRINCIPAL OBJECTIVE OF POSITION Responsible for different parenteral manufacturing operations in addition to the mechanical, electronic diagnosis and troubleshooting involving highly sensitive pharmaceutical/biologics products equipment. This will include traditional aseptic process and/or Isolator Technology process. This position must comply with all Security Guidelines, Environmental Health and Safety regulations, SOP’S and the current Good Manufacturing Practices. MAJOR DUTIES AND RESPONSIBILITIES Perform mechanical evaluation and troubleshooting Performs initial evaluation and minor troubleshooting diagnosis of manufacturing equipment failures Supports maintenance personnel in major troubleshooting diagnosis activities. Performs complex and highly technical manufacturing operations of aseptic processing and/or isolator technology such as 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. Operates in an efficient manner of the manufacturing processes to maximize product yield of products. Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses. Maintains housekeeping within controls and aseptic environments, according to procedures. Handle Hazardous and Non-hazardous waste according to EHS procedures. Receives, verifies and maintains all production records and transaction documents error free and in compliance with established procedures including computer generate transactions. Receives, handle, verifies and weights excipients, drug substances, and/or active ingredients. Performs systems integrity test 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 legible, error free and on time following good documentation practices. Performs other duties to support other functional areas such as: Assist manufacturing activities in other areas within operations as required. Initiates, participates, and assists in resolution of quality investigations. Audits batch records and documentation, as required. Revises and improves procedures and develops new SOPs based on observations and experiences. Participates in special projects, during audits and regulatory inspections as required. Participates and assists in area validation and qualification activities. Supports the Annual Requalification Program by assuring plan execution on established timeframe Attends to all mandatory