Manufacturing Operator

Piramal Pharma Limited; Lexington, Northern (KY, KY); Hybrid; USD 34,000 - 44,000; Full time

Job summary

Piramal Pharma Limited in Lexington, KY, is seeking a Manufacturing Operator to perform core production activities including preparation, filling, capping, autoclaving, and sterilization. The role supports aseptic manufacturing and requires adherence to cGMP and safety standards.

Responsibilities include equipment operation, documentation, and collaboration with quality and validation teams to ensure product quality and regulatory compliance. Night shift availability is noted for this role.

Qualifications

• Must have basic technical aptitude and ability to operate manufacturing equipment.
• Familiarity with cGMP, OSHA, and FDA requirements is preferred.
• Ability to read and follow written instructions and SOPs.

Responsibilities

• Perform component preparation, filling, capping, and aseptic operations.
• Operate and maintain production equipment and perform line clearances.
• Execute sterilization steps and lyophilization where applicable.
• Maintain clean, organized work area and document activities per regulations.
• Assist in training new operators and participate in process improvements.

Skills

Mechanical aptitude

Equipment operation

Team player

Regulatory compliance

Read and follow instructions

Attention to detail

Education

High School education or equivalent

Tools

Aseptic filling equipment

Vial washing equipment

Sterilization equipment

Job description

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. **Shift**Nights **Reporting Structure**This position reports to the Production Supervisor. **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 equipmentCollaborate 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