EXPANSION Manufacturing Operator

Piramal Pharma Limited; Lexington, Northern (KY, KY); Hybrid; USD 38,000 - 54,000; Full time

Job summary

Piramal Pharma Limited in Lexington, KY is seeking a Manufacturing Operator to perform component prep, filling, capping, sterilization, and lyophilization tasks on night shifts. Under supervision, you will operate and maintain production equipment and ensure batches meet quality and regulatory standards.

The role requires a High School diploma, 2+ years in manufacturing, and a disciplined team player attitude with strong attention to detail.

Qualifications

• High School education or equivalent.
• 2+ years in industrial/manufacturing environment.
• Pharmaceutical/aseptic manufacturing preferred.
• Strong mechanical aptitude.
• Ability to read, interpret and follow written instructions.

Responsibilities

• Operate and maintain production equipment.
• Perform line clearances, cleaning, and sterilization of fill equipment.
• Weigh, measure and verify raw materials for batches.
• Execute validation protocols for processes and equipment.
• Maintain records to ensure cGMP compliance.
• Read and follow SOPs; participate in process improvements and deviations.

Skills

Mechanical aptitude

Regulatory knowledge

Reading instructions

Team player

Attendance reliability

Education

High School diploma or equivalent

Tools

Aseptic filling equipment

Job description

EXPANSION Manufacturing OperatorJob DescriptionBusiness: Pharma Solutions Department: Operations (OPS) Location: Lexington**Job Overview**Reporting to the Production Supervisor, the Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.**Reporting Structure**This position reports to the Production Supervisor.**Shift:**Nights**Key Responsibilities:**• Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies • Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment • Operate and maintain production related equipment • Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities • Execute validation protocols for processes and equipment • Maintain records and a clean environment to comply with regulatory requirements • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures. • Review current SOPs and provide feedback on potential process improvements • Participate in troubleshooting and process improvement activities including corresponding documentation activities • Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance • Initiate appropriate action when process deviations occur • Perform on-the-job training for new and developing operators • Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment • Collaborate effectively and communicate with other functional groups, including: quality, validation, supply chain to ensure production goals are achieved**Qualifications:**• High School education or equivalent• 2+ years’ working within an industrial or manufacturing environment • Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred • Mechanical aptitude, ability to operate processing equipment • Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA) • Ability to read, interpret, and follow written instructions • Team player committed to quality and working effectively with others • Track record of consistent attendance and overall reliability