Equipment/Sterile Operator I - 3rd Shift

Hikma Pharmaceuticals • Cherry Hill, NJ

71d • $20

About The Position

The Equipment/Sterile 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. 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.

Requirements

• High School diploma or equivalent.
• Successful completion of applicable Work Instruction qualifications and gowning training.
• Strong interpersonal skills and excellent communication abilities.
• Ability to perform mathematical calculations associated with production documentation.
• Ability to comprehend and follow all applicable SOPs.
• Ability 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 push/pull trucks weighing in excess of 50 lbs.
• Must be able to stand for long periods of time.

Nice To Haves

• Prior equipment preparation, Clean Room, or sterile operator experience (including non-site experience) is preferred.

Responsibilities

• 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 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.
• 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, ultrasonic basins, timers, and bag sealers.
• Divides process closures and places 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 maintains logbooks and batch record paperwork.
• Reports manufacturing/component deviations to area Supervisor/Group Leader.
• Maintains general area housekeeping.
• Performs all other duties as assigned by supervision, including training of others.

Benefits

• Annual performance bonus, commission, and share potential.
• Auto enrollment in a Hikma-sponsored 401(k) program with a company match.
• Generous paid time off (PTO) bank starting with 20 days.
• 3 personal days.
• 11 company paid holidays.
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, and prescription drug coverage.
• Employee discount program.
• Wellbeing rewards program.
• Career advancement and growth opportunities.
• Tuition reimbursement.
• Paid maternity and parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees