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Manufacturing Operator I

2 months ago

Hilliard, Ohio, United States American Regent, Inc. Full time
Overview

This entry-level role is an integral part of the Manufacturing Team. The Manufacturing Team is tasked with the production of safe, effective, and sterile pharmaceuticals, adhering to company Standard Operating Procedures (SOPs), policies, and current Good Manufacturing Practices (cGMPs). The team ensures that aseptic and sanitary conditions are upheld as necessary, that manufacturing area and equipment records are maintained accurately, and that professional conduct is exhibited consistently. In collaboration with Production Management, the Manufacturing Team contributes to various departments as required, playing a vital role in upholding production timelines and achieving organizational objectives.

The Team Member will engage in all facets of the Manufacturing Process. This includes the semi-automatic loading of glass vials, caps, and seals into production machinery, as well as the unloading of completed products from the machinery and the setup, teardown, and clearance of manufacturing equipment. The Team Member will support all manufacturing activities under the direct supervision of Senior Manufacturing Team Members.

Key Responsibilities

Management retains the right to assign or reassign duties and responsibilities as necessary.
  • Collects, organizes, and returns production materials to facilitate manufacturing operations.
  • Assists colleagues with the assembly, cleaning, and storage of equipment as needed to support production.
  • Ensures the cleanliness of manufacturing equipment and work areas to promote efficient operations.
  • Staffs various positions to assist with container washing, filling, stoppering, and capping, and will unload finished products.
  • Participates in all training programs mandated by Company SOPs, policies, and procedures.
  • Performs additional tasks as assigned by management.
Qualifications and Requirements

To excel in this position, an individual must satisfactorily fulfill each essential duty. The following qualifications are representative of the knowledge, skills, and abilities required:
  • High School Diploma or GED is required; some college or technical training is advantageous.
  • Preferred minimum of 2 years of experience in a related field.
  • Ability to perform basic mathematical calculations.
  • Mechanical aptitude with the capability to assemble, troubleshoot, and conduct minor repairs on manufacturing equipment.
  • Ability to stand in one location for extended periods while monitoring equipment and processes.
  • Must be able to read documents in Standard English, including Standard Operating Procedures, maintenance schedules, and operating manuals.
  • Willingness to work overtime as required.
Physical Environment and Requirements
  • Must be physically capable of wearing cleanroom/protective gowning and equipment, including but not limited to gowns, goggles, face shields, respirators, and protective gloves. Personal Protective Equipment (PPE) and respirators are essential for employee health and safety.
  • Employees must maintain a clean-shaven appearance during each working shift to ensure proper fit of tight-fitting respirators.
  • Must be able to occasionally lift and/or move up to 50 pounds.
  • Physically capable of working with restricted access barrier systems or isolation containment devices.
  • Must be able to stand for prolonged periods.
  • Must adhere to cleanroom gowning and respirator fit testing requirements.
American Regent is committed to fostering diversity and creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.