Fill Operator 1 - First Shift
Position Summary
Our client, an established pharmaceutical manufacturing organization dedicated to developing, producing, and supplying high-quality medicines is seeking a Fill Operator I to join its first shift manufacturing operations team. This position supports sterile production activities within a regulated pharmaceutical environment and is responsible for equipment setup, operation, cleaning, sanitization, and production support activities. The successful candidate will follow established GMP procedures while ensuring product quality, operational efficiency, and workplace safety.
Key Responsibilities
- Maintain reliable attendance and adhere to established work schedules.
- Successfully maintain required cleanroom gowning qualifications.
- Perform manufacturing activities utilizing accepted aseptic processing techniques.
- Support one or more stages of manufacturing operations, including:
- Preparation, cleaning, and sterilization of equipment, components, and production materials.
- Weighing and dispensing raw materials for manufacturing activities.
- Setup and operation of formulation and compounding equipment.
- Operation of filling, stoppering, sealing, and related production equipment.
- Complete manufacturing records, equipment logs, and other required documentation accurately and in compliance with GMP requirements.
- Follow approved operating procedures, work instructions, and safety guidelines.
- Perform cleaning and sanitization of manufacturing equipment and controlled production areas.
- Conduct routine in-process inspections, sampling activities, and quality checks.
- Assist with equipment troubleshooting, routine inspections, and preventive maintenance activities.
- Communicate production, maintenance, quality, or safety concerns to supervision in a timely manner.
- Support manufacturing schedules that may require overtime or schedule flexibility.
- Participate in departmental initiatives and perform other duties as assigned.
Qualifications
Education
- High School Diploma required.
Required Experience
- Minimum of one year of experience operating manufacturing or production equipment.
Preferred
- Experience working in a GMP-regulated environment.
- Previous exposure to aseptic processing, cleanroom operations, or sterile manufacturing.
- Familiarity with pharmaceutical, biotechnology, medical device, or related manufacturing environments.
Skills & Competencies
Communication & Documentation
- Strong verbal and written communication skills.
- Ability to accurately complete production documentation and batch records.
- Ability to read, understand, and follow SOPs, work instructions, and safety procedures.
Technical & Operational Skills
- Ability to operate manufacturing equipment safely and effectively.
- Strong attention to detail and commitment to quality standards.
- Ability to follow established processes while maintaining compliance with GMP requirements.
Problem Solving
- Ability to identify and escalate process, equipment, or quality concerns.
- Capability to work through routine production challenges with guidance from supervisors and established procedures.
- Ability to interpret written, verbal, and visual instructions.
Mathematical Skills
- Basic math proficiency, including working with decimals, fractions, and standard units of measure.
Physical Requirements
- Ability to stand and move throughout the workday.
- Frequent bending, reaching, pushing, pulling, and lifting.
- Ability to lift and carry materials weighing up to 30 pounds.
Work Environment
- Work is performed within controlled manufacturing and cleanroom environments.
- Required use of personal protective equipment and cleanroom garments, including gloves, masks, hoods, and coveralls.
- Environment may include moderate noise levels, confined manufacturing spaces, and routine use of cleaning and sanitizing agents.
- Hearing protection may be required in designated production areas.
- Reasonable accommodations may be made to enable qualified individuals to perform the essential functions of the role.
FAQs
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