Manufacturing Operator

Piramal Pharma Limited; Lexington (VA); On-site; USD 36,000 - 54,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking a Manufacturing Operator to support production activities, including preparation, filling, capping, autoclaving, sterile processes, and lyophilization. You will report to the Production Supervisor and ensure batch records and equipment function meet cGMP standards.

The role emphasizes adherence to SOPs, training of new staff, and collaboration with quality, validation, and supply chain teams.

Qualifications

• High School education or equivalent.
• 2+ years in industrial or manufacturing environment.
• Pharmaceutical/aseptic manufacturing experience preferred.
• Mechanical aptitude and ability to operate processing equipment.
• Understand and follow cGMP, OSHA and FDA requirements.
• Read, interpret and follow written instructions.
• Team player with reliability and attendance.

Responsibilities

• Comply with policies and procedures regulated by PPS and regulators.
• Perform line clearances, cleaning and sterilization of fill equipment.
• Operate and maintain production equipment.
• Weigh and check raw materials for batch accuracy.
• Execute validation protocols for processes and equipment.
• Maintain records and a clean environment per regulatory requirements.
• Read and follow GMP and SOPs.
• Review SOPs and suggest process improvements.
• Assist in troubleshooting and documentation.
• Review batch records for quality and cGMP compliance.
• Initiate action on process deviations.
• Train new operators.
• Maintain cleanliness and routine maintenance of work area and equipment.
• Collaborate with quality, validation and supply chain to meet production goals.

Skills

Mechanical aptitude

Read and follow instructions

Team player

Regulatory awareness

Process equipment operation

Education

High School education or equivalent

2+ years in manufacturing environment

Job description

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Division

Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle.

We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Manufacturing OperatorJob Description

Business: Pharma Solutions

Department: Operations (OPS)

Location: LexingtonJob 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.

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