Fill Operator

RXinsider LTD.; Bedford (OH); On-site; USD 38,000 - 48,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Fill Operator I in Bedford, Ohio. The role covers full-spectrum duties in parts preparation, compounding, and filling, with no supervisory responsibilities.

You will perform tasks using aseptic technique in controlled environments, documenting processes and ensuring adherence to cGMP/SOPs. We value candidates with a high school diploma, at least 1 year of production-equipment experience, and ideally aseptic technique training and clean room exposure.

Qualifications

• Good oral and written communication with documentation in SOPs and batch records.
• Ability to read and interpret safety rules and operating procedures.
• Capable of performing duties with aseptic technique in cGMP environments.

Responsibilities

• Operate filling and related equipment in a cleanroom setting.
• Follow written procedures for compounding and filling rooms.
• Maintain records and perform quality checks on fill weights.
• Assist with preventive maintenance and equipment cleanliness.

Skills

Communication

Documentation

Reading manuals

Math skills

Problem solving

Education

High school diploma or equivalent

Job description

Job Title: Fill Operator I

Location: Bedford, Ohio

Job Type: Full-time

Description

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Fill Operator I.

JOB PURPOSE

The Filling Operator I 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 one or two of the following 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.
• Sets 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.
• Performs all other duties as determined by management personnel.

QUALIFICATIONS

• Minimum: High school diploma or equivalent.

EXPERIENCE

• Minimum: Minimum of 1 (one) year experience operating production equipment.
• Preferred: Prior aseptic technique training and working in a clean room environment.

SKILLS

Language 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 read and interpret written documents such as safety rules, operating and maintenance instructions and procedure manuals.
• Ability to complete required documentation such as production batch records.

Mathematical Skills:

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and/or decimals.

Reasoning Ability:

• 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.

Physical Demands:

• While performing the duties of this job, the employee is required to stand for long periods of time and must be able to lift 30 lbs. This job requires frequent bending, twisting, pushing, pulling, and lifting. Use of Sanitizing agents to maintain cleanroom environment.
• Filling Operator I must work in areas totally gowned with 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 protection may be required. The use of sanitizing agents to clean area may be moderately disagreeable.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.