Equipment/Sterile Operator I-3rd Shift

About the role

We are seeking a talented and motivated Equipment/Sterile Operator I for the 3rd shift (Sunday–Thursday). In this role, you will undergo a minimum of twelve (12) months of supervised training in the preparation of components used in the filling and compounding process, filter integrity testing, product sterilization, and aseptic gowning. Training progresses through four phases:

• Phase I: Preparation of components, including documentation, bagging, sealing, and inventory management using an RF gun system.
• Phase II: Membrane Integrity Testing (MIT) of filters, interpretation of results, and preparation of miscellaneous items, tubing, and filters for Filling or Compounding.
• Phase III: Product terminal sterilization using autoclaves, including documentation and interpretation of chart readings.
• Phase IV: Aseptic gowning, sanitization, and plating.

Upon successful completion of training and qualifications, you will receive an hourly rate increase and advance to learning Equipment/Sterile Operator II skills, including cleaning, preparing, and sterilizing equipment, and performing sterile operations.

Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Read and follow filling schedules, SOPs, and Work Instructions.
• Prepare miscellaneous items, tubing, and filters for Filling or Compounding.
• Operate cleaning equipment (e.g., Crest Ultrasonic Washers, Girton Washers, WFI panels, thermometers, pressure gauges).
• Demonstrate proper documentation practices.
• Move and load carts/trucks from autoclaves.
• Complete gowning qualification and aseptic training.
• Operate steam autoclaves and hot air ovens, including load configurations, parameter sheets, and chart interpretation.
• Verify incoming materials for quantity and correctness using Bill of Materials.
• Calculate closures required based on Bill of Materials.
• Operate closure preparation equipment (balances, ultrasonic basins, timers, bag sealers).
• Monitor gauges and temperature readings.
• Divide process closures and place correct quantities into sterilizable breather bags.
• Calculate expiration dates for processed closures and set up label/RF guns for printing.
• Perform clean and clearance of work area; complete logbooks and batch record paperwork.
• Report manufacturing/component deviations to supervision.
• Maintain general area housekeeping.
• Perform additional duties as assigned, including training others.

Requirements

• High School diploma or equivalent.
• Strong interpersonal and communication skills; ability to interact across departmental boundaries.
• Excellent English language comprehension (written and verbal).
• Ability to perform mathematical calculations (whole numbers, fractions, decimals) for production documentation.
• Ability to follow SOPs and interpret pressure/temperature charts and process control documents.
• Must be able to lift 25–50 lbs. and push/pull trucks over 50 lbs.
• Ability to stand for long periods.
• Work in a controlled environment with moderate to loud noise; hearing protection may be required.
• Work with WFI (water for injection) at temperatures exceeding 50°C and pressure vessels (autoclaves).
• Use of latex/protective gloves; gown qualification for clean room environments.
• Exposure to steam, high-temperature equipment, and potential minor injuries (cuts, abrasions, burns, muscle strains).

Qualifications

• Minimum: Successful completion of applicable Work Instruction qualifications and gowning training.
• Preferred: Prior equipment preparation, clean room, or sterile operator experience (non-site experience considered).

Pay

Starting hourly rate: $20.00. Compensation may vary based on work location, prior experience, job-related knowledge, skills, and market factors. Details will be provided during the hiring process.

Schedule

3rd shift: Sunday–Thursday.