This position involves a minimum supervised training in the preparation and sterilization of equipment and components used in the filling and compounding process. Training will start with equipment/component preparation duties and progress into responsibilities for the sterilization of processing equipment/Components and finished product. 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 disassembly, cleaning, and preparation of factory equipment. Including but not limited to proper documentation and use of required cleaning equipment. Demonstrate ability to calculate waste bulk quantities and properly dispose of material. Ongoing duties will then be assigned to include cleaning and preparation of equipment for sterile processing,

Phase II – Demonstrate complete familiarity with the use of steam sterilizers, ovens and hot air drying ovens, including but not limited to proper documentation and ability to interpret chart readings and recorders. Once qualified, employee will be expected to load and run sterilization equipment in a sterile controlled environment.

Phase III – Complete training on product terminal sterilization on all finished product autoclaves.

• Regular and predictable onsite attendance and punctuality.
• The disassembly, cleaning, and assembly of processing equipment used in the filling operation.
• Preparation of miscellaneous equipment and compounding items.
• Sterilization of equipment and components in accordance with cGMP’s and departmental SOP’s/Job Aids.
• Sterilization of finished product in accordance with cGMP’s and departmental SOP’s.
• Clear and accurate documentation of all processing steps as required.
• Ability to read filling schedule or Equipment Inventory Sheets to determine equipment/miscellaneous items to be prepared.
• Ability to read and follow applicable SOP’s, Job Aids, and Standard Set-up Sheets following training period.
• Preparation of miscellaneous items, tubing, and filters required 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.
• Disassembly, cleaning and re-assembly of processing equipment.
• Demonstrated knowledge of proper documentation practices.
• Movement and loading of carts/trucks from ovens and autoclaves to sterile storage areas.

• 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.
• Performs all duties required for Component Preparation as follows:
  • Calculates the correct number of closures required based on Bill Of Materials.
• • Operates a wide range of closure preparation:
• 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
  • 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.

QUALIFICATIONS

• Minimum:
• High School diploma or equivalent
• Successful completion of applicable Job Aid qualifications including 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 and aseptic area environment. In aseptic areas employees must be totally gowned with mask, hood, coverall and gloves. At times environment can be confining.
• 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

• Paid time off

• Company holidays
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities

• 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.