Fill Operator I - Lyo - 1st Shift

About the role

Location: Bedford, Ohio. Job Type: Full-time. 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.

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.

Requirements

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Qualifications

• 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