Equipment​/Sterile Operator

Equipment/Sterile Operator I

Job Title:

Equipment Sterile Operator I - 1st Shift (Sunday
-Thursday)

Location:

Cherry Hill, NJ

Job Type: Full-time

Req

ABOUT US:

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.

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.

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 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 (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).

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.

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…