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
