Fill Operator II

Job Title: Fill Operator II

Location: Bedford, Ohio

Job Type: Full-time

Req ID: 10707

 

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

The Filling Operator II will be responsible for the full spectrum of duties in controlled Parts Preparation, Compounding/Formulation, and Filling.  This job has no supervisory responsibilities.

 

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Maintains curriculum Gowning-Qualifications.
• Ability to perform all job duties using acceptable aseptic technique.
• Ability to perform job duties in multiple areas of manufacturing to include:
• Parts and production preparation to include use of Parts Washer and Autoclave.

• • Dispensing of excipients and API in preparation for compounding.
  • Set up and operates Compounding/Formulation tanks and equipment.
  • Sets up & operates automated filling and support equipment such as filler/isolator, filter and glove testing.

• Completes applicable paperwork and logbook entries for compounding and filling rooms in accordance with approved procedures.

• Follows all written procedures for operation of the compounding and fill rooms.
• Performs clean-up of equipment and room, including walls and floor, as necessary.
• Collects samples, performs fill weight checks and other quality checks as necessary.
• Assists with or performs preventive maintenance tasks on compounding and filling equipment, such as inspection and cleaning of machine parts, as may be required.

• Refers process issues to Supervisor or designee

• Informs supervisor of maintenance and/or safety issues.

• Works overtime with short notice when production requires.
• Lead Turnaround/Changeover activities
• Ability to train others
• Performs all other duties as determined by management personnel.
• All other duties as assigned.

 

QUALIFICATIONS

• Minimum: High School diploma or equivalent.

 

EXPERIENCE

• Minimum: Minimum of 3-4 years experience operating production equipment, previous aseptic and clean room environment experience.

 

SKILLS

• Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.  Ability to examine problem areas and make recommendations for corrective action.
• Must be able to comprehend and follow all applicable SOPs.
• Must be able to lift 30 lbs.
• Must be able to stand for long periods of time.
• The cleaning function of the position requires frequent bending, twisting, pushing, pulling and lifting. 

• Filling Operator II must work in areas totally Gowned with a mask, hood, coverall and gloves. The conditions are difficult to work in.  At times the environment can be confining. The noise level is moderate to loud.  Use of hearing protectio