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Manufacturing Operator

Piramal Pharma Solutions -
Lexington, KY

Quick Apply

Job Details

Full-time
$22 an hour

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Referral program
Retirement plan

Qualifications

Machine operation
High school diploma or GED
Manufacturing facility experience
Staff training
Industrial equipment
Training & development
FDA regulations

Full Job Description

Company Overview
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) dedicated to delivering comprehensive solutions across the entire drug development and manufacturing spectrum. With a global network of facilities, we support clients through innovative services in drug discovery, process development, clinical supplies, and commercial manufacturing of APIs and finished dosage forms.

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 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

Pay: $22.00 per hour

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Referral program
Retirement plan
Tuition reimbursement
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

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