JOB PURPOSE

Operator I position involves 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 will start with component preparation duties and progress into responsibilities for MIT Testing, preparation of miscellaneous items, tubing, and filters, sterilization of finished product and aseptic gowning.  The training activities would be expected to progress in the following manner or until which time the incumbent has completed the required qualifications and has demonstrated the confidence and proficiency to conduct his or her work independently:

 

Phase I – Demonstrate complete familiarity with the preparation of components, including but not limited to proper documentation, proper bagging and sealing processes and ability to inventory/manage through the RF Gun process.  Once qualified, employee will be expected to prep components and scan to appropriate staging/storage, prep and usage area using the RF system.

 

Phase II – Demonstrate complete familiarity with the testing of filters for Membrane Integrity Testing (MIT) and use of filter integrity test units, including but not limited to proper documentation, recognition of filter types/class and ability to interpret results.  Once qualified, employee will be expected to conduct filter testing and document appropriate test results. Additionally, demonstrate complete familiarity with preparation of miscellaneous items, tubing, and filters required by Filling or Compounding.

 

Phase III – Demonstrate complete familiarity with product terminal sterilization on all finished product autoclaves including but not limited to proper documentation and ability to interpret chart readings and recorders.  Once qualified, employee will be expected to sterilize product loads in accordance with applicable procedures.

 

Phase IV – Demonstrate the ability to aseptically gown including but not limited to aseptic gowning, proper sanitization, and proper plating.

 

Upon successful completion of the above training program and applicable job qualifications, the incumbent will receive an hourly rate increase.  The employee will utilize the skills developed as an Equipment/Sterile Operator I to learn the skills of an Equipment/Sterile Operator II and clean, prepare and sterilize equipment and perform sterile operations on a rotational basis with co-workers or as directed by area management. Upon successful completion of learning the Equipment/Sterile Operator II skills, the incumbent will receive an hourly rate increase and advance to the Equipment/Sterile Operator II role.

KEY ACCOUNTABILITIES

Regular and predictable onsite attendance and punctuality. Ability to read filling schedule. Ability to read and follow applicable SOP’s and Work Instructions following training period Preparation of miscellaneous items, tubing, and filters reuqired by Filling or Compounding  Use of cleaning equipment including but not limited to Crest Ultrasonic Washers, ultrasonic basins, Girton Washers, WFI point of use panels, thermometers, pressure gauges, etc. Demonstrated knowledge of proper documentation practices. Movement and loading of carts/trucks from autoclaves. Successful completion of gowning qualification and aseptic training. Ability to understand and use operational procedures for steam autoclaves and hot air oven. Demonstrated knowledge and understanding of proper load configurations, parameter sheets, interpreting of pressure and temperature charts, and associated documentation. Performs/executes on-the-job training tasks as required when qualified. Adheres strictly to cGMPs and SOPs to ensure the quality and integrity of products. Verifies incoming materials for quantity and correctness using Bill Of Materials. Calculates the correct number of closures required based on Bill Of Materials. Operates a wide range of closure preparation equipment such as: Balances (Used to weigh closures) Ultrasonic basins (used to wash closures) Timers (Used to monitor validated wash times) Bag sealers (To seal sterilizable breather bags) Monitor gaugues and temperature reading.   Divides process closures and place correct quantity into sterilizable breather bags. Calculates expiration dates for processed closures. Setup hand held label gun with expiration date, quantity per bag, and print labels for each bag of  closures. Set up hand held RF gun to confirm expiration/retest date, quantities, and print labels for each bag of  closures. Performs clean and clearance of work area. Completes and maintain logbooks and batch record paperwork. Report manufacturing/component deviations to area Supervisor/Group Leader Maintain general area housekeeping. Performs all other duties as assigned by supervision, including training of others

 

QUALIFICATIONS

High School diploma or equivalent

 

EXPERIENCE

Minimum:   Successful completion of applicable Work Instruction qualifications and gowning training

Preferred:   No prior Equipment Prep experience is required however, preference would be given to candidates having prior equipment preparation, Clean Room, or sterile operator experience (including non-site experience)

 

Candidate should have strong interpersonal skills and be an excellent communicator who can successfully interact and coordinate activities across departmental boundaries and at varying levels within the organization. Excellent English language comprehension, both written and verbal. Ability to perform mathematical calculations associated with production documentation using whole numbers, common fractions and /or decimals. Follows set guidelines or procedures. Must be able to comprehend and follow all applicable SOPs. Must be able to understand and interpret pressure and temperature charts and other associated process control documents. Ability to work safely. Must be able to lift between 25-50 lbs. and pushing/pulling trucks weighing in excess of 50 lbs. Must be able to stand for long periods of time. Works in a controlled environment. The noise level is moderate to loud. Use of hearing protection may be required. Works with WFI (water for injection) at temperatures in excess of 50 degrees C. Use of latex and /or protective gloves is required for most tasks. Must be gown qualified to work in a clean room environment. May incur minor cuts, abrasions, bruises, slight burns, or muscle strains. Exposure to steam, high temperature equipment and water (WFI), and must work with pressure vessels (autoclaves).

 

What We Offer

Clean climate-controlled working environment Annual performance bonus potential 401k employer match up to 6% of your contributions 23 vacation/personal days 11 paid Company holidays Generous healthcare benefits Employee discount program Wellbeing rewards programs Safety and Quality is a top organizational priority Career advancement/growth opportunities Tuition Reimbursement Maternity and Parental Leave

 

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms