Manufacturing Operator I - Specialty Injectables

Tolmar; Windsor (CO); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Equitable compensation

Strong benefits package

Equal Opportunity Employer

Job summary

Tolmar, located in Windsor, Colorado, is seeking a Manufacturing Operator I for Specialty Injectables. This role focuses on basic setup and operation of manufacturing processes in a clean room environment, ensuring high-quality standards. The successful candidate will learn aseptic techniques and good manufacturing practices.

Responsibilities include adhering to safety protocols, performing inspections, and maintaining equipment. Candidates must have a high school diploma and relevant manufacturing experience. Strong attention to detail is essential for this position. Tolmar offers competitive compensation and benefits.

Qualifications

• High school diploma or GED required, bachelor’s degree preferred.
• 1-2 years of technical/manufacturing experience is desirable.
• Strong knowledge of cGMP is essential.

Responsibilities

• Set up and operate manufacturing processes in compliance with cGMP.
• Perform operations involving sterile filling and bulking.
• Adhere to safety protocols and maintain clean room standards.

Skills

Aseptic Technique

Good Manufacturing Practices (cGMP)

Attention to Detail

Basic Computer Skills

Education

High School Diploma or equivalent

Bachelor’s Degree or equivalent experience

Job description

A Shift: Sunday - Wednesday, 5:00 am - 5:30 pm, every other Wednesday off

B Shift: Sunday - Wednesday, 5:00 pm - 5:30 am, every other Wednesday off

C Shift: Wednesday - Saturday, 5:00 am - 5:30 pm, every other Wednesday off

D Shift: Wednesday - Saturday, 5:00 pm - 5:30 am, every other Wednesday off

Purpose and Scope

The Manufacturing Operator I – Specialty Injectables is responsible for basic setup and operation of manufacturing processes, with a focus on learning aseptic technique and GMP standards. This role performs basic setup and operation of processes supporting the Specialty Injectable team, ensuring products are made with quality for patients. This role will focus on Injectables (Sterile Filling/Bulking), Bulking (Polymer), or both.

Key Responsibilities

Maintaining High Standard of GMP

• Adherence to Good Manufacturing Practices (cGMP) as they relate to sterile injectable manufacturing
  • Learn to 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
• Participates in annual hazardous waste training
• Learn to handle 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.
• Learn and support maintaining clean room standards and ensure adherence to safety protocols.
• Learns and accurately executes visual and physical checks of in-process and finished product
• Learns and 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
• Learn and adhere to all gowning procedures.

Technical Skills

• Learns, develops basic understanding, follows guidance and support
  • Equipment set up, operation, disassembly and cleaning .
  • Sterile bulking process sterile using enclosed equipment train
  • Reading technical drawings/documents on the floor.
  • Operation of HMI systems to verify accurate functionality.
  • Contacting Maintenance as needed to resolve issues e.g filter testing/ pressure hold test/ milling/ SIP/VHP, PMS, autoclave
  • 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.
• Working knowledge of filling aseptic technique. Understanding of contamination control and clean room practices
  • Correctly performs aseptic interventions as per procedure
• Sets up and operates 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.

Other

• Learn to participate in triage of atypical events with Quality, Maintenance, and MFG leadership as needed.
• Participates in on-the-job training for aseptic techniques equipment operation.
• Performance Metrics: Evaluated on accuracy, compliance and reliability in documentation and process execution
• Perform other duties as required.

Knowledge, Skills & Abilities

• Strong 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.

Core Values

• Center on People: We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands‑on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity,inclusion& sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• High school diploma or equivalent required.
• Bachelor’s Degree required, or equivalent combination of education and experience as follows:
• High School Diploma or GED and 1 to 2 years of technical/manufacturing experience.

Working Conditions

• Shift work in a manufacturing and warehouse environment.
• May require overtime and occasional weekend work.

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidate’s qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.