Manufacturing Operator

Piramal Pharma Limited; Lexington (KY); Hybrid; USD 38,000 - 60,000; Full time

Job summary

Piramal Pharma Limited in Lexington, KY is seeking a Manufacturing Operator to perform production activities including preparation, filling, capping, autoclaving, terminal sterilization, and lyophilization.

Under the supervision of the Production Supervisor, you will operate and maintain equipment, ensure strict cGMP compliance, read and follow SOPs, and participate in process improvements while maintaining accurate records. This full-time role emphasizes reliability and teamwork.

Qualifications

• High school education or equivalent required.
• Mechanical aptitude and ability to operate processing equipment.
• Knowledge of cGMP, OSHA, FDA regulations preferred.
• Team player with reliable attendance and dependability.

Responsibilities

• Comply with policies and procedures regulated by PPS and agencies.
• Operate and maintain production equipment and fill/sterilize processes.
• Weigh and check materials for correct batches.
• Execute validation protocols and document results.
• Read, understand and follow GMP and SOPs; suggest improvements.
• Train new operators and support cross-functional collaboration.
• Maintain clean work area and ensure regulatory records are complete.

Skills

Mechanical aptitude

Team player

Regulatory knowledge

Attention to detail

Reading instructions

Education

High School education or equivalent

Job description

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

Shift: Days

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 instructionsTeam player committed to quality and working effectively with others
• Track record of consistent attendance and overall reliability

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law.

Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.