Fill Operator I - IV Bags - 1st Shift

Location: Bedford, Ohio · Full-time · Req ID: 12247

About the role

We are seeking a talented and motivated Fill Operator I. In this role, you will be responsible for the full spectrum of duties in controlled filling and ancillary rooms, including set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, and related tasks.

Responsibilities

• Regular and predictable onsite attendance and punctuality
• Maintains curriculum gowning qualifications
• Ability to perform all job duties using acceptable aseptic technique
• Perform job duties in one or two of the following manufacturing areas:
  • Parts and production preparation including use of Parts Washer and Autoclave
  • Dispensing of excipients and API in preparation for compounding
  • Set up and operate Compounding/Formulation tanks and equipment
  • Set up & operate automated filling and support equipment such as filler/isolator, stoppering units, and cappers
• Complete applicable paperwork and logbook entries for compounding and filling rooms in accordance with approved procedures
• Follow all written procedures for operation of the compounding and fill rooms
• Perform clean-up of equipment and room, including walls and floor, as necessary
• Collect samples, perform fill weight checks and other quality checks, as necessary
• Assist with or perform preventive maintenance tasks on compounding and filling equipment, such as inspection and cleaning of machine parts
• Refer process issues to Supervisor or designee
• Inform supervisor of maintenance and/or safety issues
• Work overtime with short notice when production requires
• Perform all other duties as determined by management personnel

Qualifications

• Minimum: High School diploma required
• Experience Minimum: Minimum of one year experience operating production equipment
• Preferred: Prior aseptic technique training and working in a clean room environment

Skills

• Language Skills: Good oral and written communication skills; ability to document process issues cleanly and concisely per cGMPs and SOPs; ability to read and interpret safety rules, operating/maintenance instructions, and procedure manuals; ability to complete production batch records
• Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure using whole numbers, common fractions, and decimals
• Reasoning Ability: Apply common sense understanding to carry out instructions in written, oral, or diagram form; deal with problems involving several concrete variables in standardized situations; examine problem areas and make recommendations for corrective action; comprehend and follow all applicable SOPs

Physical Demands

Required to stand for long periods and lift 30 lbs. Frequent bending, twisting, pushing, pulling, and lifting.

Work Environment

Work in filling suites fully gowned with mask, hood, coverall, and gloves; environment can be confining. Noise level is moderate to loud; hearing protection may be required. Use of sanitizing agents to clean the filling room may be moderately disagreeable. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Pay

Hourly Rate: $22.00 per hour. Compensation will be determined during the interview process and varies based on work location, prior experience, job-related knowledge, relevant skills and expertise, current business needs, and market factors.