MF Operator II - Specialty Injectables

Tolmar Careers • Windsor, CO

1d • Onsite

About The Position

The Manufacturing Operator II is responsible for executing manufacturing processes with a focus on Good Manufacturing Practice (GMP) compliance, aseptic proficiency and technical proficiency. This role demonstrates growing technical expertise, reliability in documentation, and begins mentoring junior staff. Operator II may have a primary focus of either Injectables (Sterile Filling/Bulking) or Bulking (Polymer) or both.

Requirements

• Good working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Strong knowledge of basic computer software Windows, Electronic Batch Records and other automated equipment.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Excellent verbal and written communication skills.
• Interact with peers and members of other departments in team settings in a professional manner.
• Ability to follow and understand written production records and validation protocols.
• Understanding of basic math and writing skills to document production activities in batch records and/or logbooks.
• Ability to keep accurate records and able to perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail required for documentation in production documents and to inspect produced goods within specified requirements.
• Capability to operate on a fast-paced manual assembly line using production equipment.
• Ability to learn Aseptic techniques and work in an aseptic environment.
• Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
• Ability to lift up to 40 lbs.
• Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
• Ability to provide support as well as directions to Process Development personnel in the area.
• Ability to operate new production equipment with little to no previous experience.
• Ability to lead others in proper aseptic technique and work in an aseptic environment.
• Ability to receive passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
• High school diploma or equivalent required.
• STEM Bachelor’s Degree required, or equivalent combination of education and experience as follows: Non-STEM degree and 1 or more years of technical /manufacturing experience, Technical Associate’s Degree and 2 or more years of technical/manufacturing experience or High School Diploma or GED and 4 or more years of technical/manufacturing experience.
• Six Sigma Green Belt or equivalent preferred.

Nice To Haves

• Black Belt or Green Belt certification in Lean Six Sigma or equivalent will be accepted in lieu of one year of experience.

Responsibilities

• Maintaining High Standard of GMP: Good working knowledge of current Good Manufacturing Practices (cGMP) as they relate to sterile injectable manufacturing. Accurately execute and document batch record activities in compliance with GMP and SOP requirements. Properly perform job duties ensuring all production activities and cleaning are correctly performed on batch records in accordance with cGMP standards. Demonstrate reliability and accuracy in all documentation and compliance activities.
• Compliance with safety protocols and clean room gowning requirements: Coordinates and participates in annual hazardous waste training. Handling hazardous raw materials and cleaning solutions as per safety procedures. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures. Maintain clean room standards and ensure adherence to safety protocols.
• Visual and physical checks of in-process and finished product: Performs job in a clean room environment requiring clean room gowning, including but not limited to: Company-provided Scrubs, Shoe Covers and Sterile Boot Covers, Hairnets (and beard covers as applicable), Tyvek Coveralls, Gloves, Full-face masks/hoods, Goggles, Chemical Protection PPE. Ensures peers/ junior staff adhere to all gowning procedures.
• Technical Expert: Troubleshoot equipment and process issues with increasing independence and direct supervision. Competently sets up, operates, disassembles, and cleans complex production equipment. Good working knowledge of the sterile enclosed equipment train and bulking process. Understands and executes accurately technical drawings on the floor. Basic knowledge of HMI systems to verify accurate functionality. Basic troubleshooting for resolution of equipment and process issues. Reads and understands reports and supports Maintenance as needed to resolve issues e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave. Good working knowledge of Product Quality and Equipment: cause and effect related to product quality and equipment e.g valve set up, impact, and pressure safety for gaskets and steam. Participate in continuous improvement and deviation investigations. Troubleshoot equipment and process issues with increasing independence. Show proactive engagement in technical problem-solving and process optimization.
• Other: Supports the escalation and triage of atypical events with Quality, Maintenance, and MFG leadership.
• Training and Development: Participates in on-the-job training for advanced equipment operation and troubleshooting.
• Performance Metrics: Evaluated on accuracy, compliance, reliability, and problem-solving in documentation and process execution. Prepare for advancement by mastering routine tasks and demonstrating attention to detail. Master of equipment ownership and process troubleshooting.
• Injectables Specific Responsibilities: Correctly performs aseptic interventions as per procedure. Good working knowledge of filling aseptic technique and troubleshooting of filler: understanding of contamination control and clean room practices. Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas. Set-up and operate equipment connected with Bulking process. Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes. Perform biological sampling of general manufacturing clean room facilities. Perform 100% inspections of pre-filled syringes.
• Polymer Specific Responsibilities: Perform the setup/operation/disassembly and cleaning of production bulking, milling and packaging equipment independent of maintenance personnel oversight. Complete cleaning, inspection and lubrication tasks on all Polymer area production equipment. Act as liaison between operations and maintenance staff when maintenance requirements are beyond the capability/scope of manufacturing personnel. Formulate bulk materials. Perform other duties as required.

Benefits

• Pay: $29.00 - $32.00 per hour depending on experience
• Shift Differential B Shift: $2.50 per hour
• Shift Differential D Shift: $4.50 per hour
• Benefits information: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level