MF Operator I - Pali

$48,526 - $48,526/Yr

Tolmar - Windsor, CO

Full-time - Entry Level

Windsor, CO

Food Services and Drinking Places

About the position

The Manufacturing Operator I - Pali position is a full-time role based in Windsor, CO, with core hours set from 9:00 AM to 5:30 PM, Monday through Friday throughout 2024. Starting in 2025, the team will transition to a third shift, working from 10:00 PM to 6:30 AM, with a shift differential of $2.50 per hour added to the base pay. The operator will be responsible for performing job duties in accordance with standard operating procedures (SOPs) and production records, with a strong emphasis on achieving accuracy and quality, encapsulated in the expectation of "Right the First Time." The role requires meticulous data recording in notebooks or lab forms, along with accurate calculations to support the manufacturing process. Operators will work in a clean room environment, necessitating the use of company-provided personal protective equipment (PPE) such as scrubs, shoe covers, hairnets, gloves, and goggles. Key responsibilities include setting up and operating labeling equipment for pre-filled syringes and vials, as well as semi-automatic packaging equipment. Operators will also be involved in formulating bulk materials, weighing and measuring raw materials, and maintaining a clean and compliant manufacturing environment according to current Good Manufacturing Practices (cGMP). In addition to these tasks, the operator will assist with minor maintenance on aseptic production equipment, perform facility cleaning, and ensure product quality adheres to approved specifications. The role also involves handling hazardous materials safely and supporting aseptic process development activities as directed by the Aseptic Development Operations Manager. The position requires a commitment to Tolmar's core values, including ethical operation, ownership of actions, and a collaborative spirit.

Responsibilities

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of 'Right the First Time'.
• Record data in notebooks or lab forms and accurately calculate results to support process.
• Perform job in a clean room environment requiring clean room gowning, including but not limited to company-provided scrubs, shoe covers, hairnets, Tyvek coveralls, gloves, full-face masks, and goggles.
• Set up and operate labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas.
• Properly load pre-filled syringes and/or vials into labeling equipment.
• Set up and operate semi-automatic packaging equipment used to package pre-filled syringes.
• Properly load pre-filled syringes and components into semi-automatic packaging equipment.
• Formulate bulk materials and weigh, measure, and check raw materials to assure batches contain proper ingredients and quantities.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
• Set up and operate bulking operations and identify need for minor maintenance on aseptic production equipment.
• Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
• Ensure that product quality adheres to approved specifications.
• Assist and support any aseptic process development activities/projects as determined by Aseptic Development Operations Manager.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• Perform other duties as assigned.

Requirements

• High school diploma or equivalent required.
• Two or more years of experience in a manufacturing role required.
• One or more years of experience in an aseptic (sterile) manufacturing environment preferred.
• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Understanding of basic computer software.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Good verbal and written communication skills.
• 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 log books.
• Must be able 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.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to learn Aseptic technique 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.

Benefits

• Pay: $23.33 per hour
• Equitable, fair pay practices including market-based base pay and a strong benefits package.