What are the responsibilities and job description for the Manufacturing Operator position at Piramal Enterprises?
Business: Pharma Solution
Department: Operations
Location: Lexington
Job Overview
The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.
Reporting Structure
Reporting to Manufacturing 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
Experience
- 2 years’ working within an industrial or manufacturing environment
- Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred
Education
- High School education or equivalent
Competencies
- 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
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
