MF Operator II - Specialty Injectables

Tolmar • Windsor, CO

20h • $29 - $32 • 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 Practices (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.

Nice To Haves

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

Responsibilities

• 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.
• 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.
• Ensures peers/ junior staff adhere to all gowning procedures.
• 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.
• Supports the escalation and triage of atypical events with Quality, Maintenance, and MFG leadership.
• Participates in on-the-job training for advanced equipment operation and troubleshooting.
• 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.
• 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.
• 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
• 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