Equipment / Sterile Operator I - 1st Shift

Job Title : Equipment Sterile Operator I - 1st Shift

Shift :   Monday - Friday, 7 : 00am to 3 : 30pm

Location :   Cherry Hill, NJ

Job Type :   Full-time

About Us :

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE

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 :

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.

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)

Compensation :

Hourly Rate : $20.00 per hour. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer

Recruiters :

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer :

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.