Fill Operator I - Lyo - 1st Shift

RXinsider LTD.; Bedford (OH); On-site; USD 26,000 - 34,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Fill Operator I in Bedford, OH. The role covers full spectrum duties from setup to operation in controlled filling and ancillary rooms, including sanitation and PM activities.

You will perform aseptic tasks, log relevant data, and ensure compliance with SOPs and safety standards. Candidates should have a high school diploma and at least one year operating production equipment; aseptic technique training is a plus.

Qualifications

• High School diploma required.
• At least 1 year of experience operating production equipment.
• Aseptic technique training and clean room experience preferred.

Responsibilities

• Maintain on-site attendance and punctuality.
• Operate and set up filling and related equipment under aseptic conditions.
• Complete documentation and logbooks per SOPs and cGMPs.
• Perform routine cleaning, maintenance checks, and quality checks.
• Escalate issues to supervisor and follow safety guidelines.

Skills

Communication skills

Documentation

Problem solving

Reading instructions

Education

High School diploma

Tools

Autoclave

Parts Washer

Filling equipment

Job description

Job Title: Fill Operator I

Location: Bedford, Ohio

Job Type: Full-time

Req ID: 12247

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. In this role, you will be responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, airlock and ancillary room cleaning, etc.

Key Responsibilities

• 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, stoppering units, and cappers.
• 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

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Minimum: High School diploma required.

Experience

• Minimum: Minimum of 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 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.
• Ability to examine problem areas and make recommendations for corrective action.
• Must be able to comprehend and follow all applicable SOPs.

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.

Work Environment

• Filling Operator I must work in filling suites totally gowned with mask, hood, coverall, and gloves. At times 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 the filling room may be moderately disagreeable. 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.

Compensation

Hourly Rate: $22.00 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.

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