Manufacturing Operator

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Division

Piramal Pharma Solutions

Piramal 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 Operator

Job Description

Business: 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.

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