Manufacturing Operator

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 28,000 - 34,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, Kentucky is seeking a Manufacturing Operator for the night shift to support the OPS department. You will perform component preparation, filling, capping, sterilization, and lyophilization, while ensuring compliance with GMP, cGMP and safety procedures.

Responsibilities include equipment operation, line clearances, cleaning, documentation review, and participation in process improvements.

Qualifications

• Prior work in a manufacturing facility preferred.
• Experience with aseptic processes is advantageous.
• Knowledge of cGMP, OSHA and FDA requirements is preferred.
• Ability to follow written procedures and batch records precisely.

Responsibilities

• Perform production tasks including material prep, filling, capping and lyophilization.
• Operate and maintain production equipment and perform line clearances.
• Follow SOPs and maintain clean, regulated work areas.
• Assist in process validations and report deviations promptly.
• Collaborate with quality, validation and supply chain teams to meet goals.
• Record accurate production data and ensure traceability.
• Train new operators and support housekeeping activities.

Skills

Industrial manufacturing

cGMP basics

Mechanical aptitude

Reading instructions

Team player

Attendance reliability

Aseptic manufacturing awareness

Quality mindset

Education

High School diploma or equivalent

Job description

Be the First to ApplyDivisionPiramal 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.comJob TitleManufacturing OperatorJob DescriptionBusiness: Pharma SolutionsDepartment: Operations (OPS)Location: LexingtonJob OverviewReporting to the Production Supervisor, the Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.ShiftNightsReporting StructureThis 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 achievedQualifications:• 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