Manufacturing Operator I - Polymer

Tolmar; Windsor (CO); On-site; USD 42,000 - 62,000; Full time

Job summary

Tolmar seeks a Polymer Operator to support the polymer team, ensuring products are produced with quality per cGMP standards. The role requires clean room gowning and strict adherence to SOPs, with responsibilities from operating equipment to documenting production activities in regulated records, while maintaining a clean, compliant manufacturing environment.

Qualifications

• Knowledge of cGMP and GMP manufacturing practices.
• Ability to stand for extended periods (8+ hours).
• Proficiency with basic computer software and production records.

Responsibilities

• Operate equipment for polymer manufacturing and polymer synthesis.
• Perform duties per SOPs with Right the First Time expectation.
• Document production activities using controlled production records and log books.
• Sanitation and assembly/disassembly of equipment for manufacturing.

Skills

cGMP knowledge

Stand long hours

Computer software

Detail-oriented

Verbal & written communication

Documentation skills

Education

High school diploma or equivalent

Tools

Computer software

Job description

The Polymer Operator performs routine activities related to supporting the polymer team, while ensuring that products are made with quality and in accordance with Good Manufacturing Practices.

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of “Right the First Time.”
• Perform 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
  • Face mask
  • Full Face-Respirator or PAPR (Powered Air Purifying Respirator)
• Properly perform the “Done By” function on batch records in accordance to cGMP standards.
• Assist in the set-up of equipment used to make commercial polymer.
• Operate equipment for polymer manufacturing and polymer synthesis.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Perform biological sampling of general manufacturing clean room facilities.
• Document production activities using regulatory controlled documents including production records and log books.
• Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and per Tolmar Standard Operating Procedures.
• Ensure that the quality of product being produced on assigned production line meets specified standards.
• Operate under the direct supervision of a Lead Operator and/or Supervisor.
• Participate in required annual hazardous waste training. 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.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Working knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Working knowledge of 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.
• Attention to detail for documentation in production documents and to compare produced goods against specified requirements.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to legibly complete required documentation.
• Attention to detail for documentation in production documents and to compare produced goods against specified requirements.

Core Values

This role is expected to operate within the framework of Tolmar’s Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating 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.
• 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 collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• 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.

Communication

• Interact with peers and members of other departments in team settings in a professional manner.

Education & Experience

• High school diploma or equivalent required
• 1 or more years of experience in a GMP manufacturing environment.

Additional Requirements

• Valid driver’s license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.

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 candidates 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.