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Division
Piramal Pharma Solutions
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
Machine Technician II
Job Description
The Machine Technician - Manufacturing is responsible for maintaining the efficient operation of manufacturing and packaging equipment, including equipment setup, changeovers, troubleshooting, preventive maintenance, and calibration activities. This role supports manufacturing operations by ensuring equipment reliability, product quality, compliance with cGMP requirements, and adherence to safety standards. The Machine Technician will work cross-functionally with Operations, Maintenance, Quality, and Engineering to support production goals and continuous improvement initiatives.
Essential Duties and Responsibilities
- Operate, set up, adjust, disassemble, assemble, and clean manufacturing and packaging equipment in accordance with approved procedures.
- Perform equipment changeovers and line clearances to support production schedules.
- Troubleshoot equipment issues and assist in identifying root causes of mechanical and operational problems.
- Perform routine preventative maintenance and basic equipment calibrations.
- Read, review, and comply with Standard Operating Procedures (SOPs), batch records, and training requirements.
- Complete production documentation accurately and in compliance with cGMP requirements.
- Perform electronic transactions and maintain departmental metrics using manufacturing systems and related software.
- Support manufacturing investigations, deviations, CAPAs, and corrective actions as needed.
- Assist with reviewing and updating SOPs, work instructions, and operational documentation.
- Participate in work scheduling and continuous improvement initiatives to increase equipment reliability and operational efficiency.
- Complete departmental skills inventories and become cross-trained on equipment and processes within other manufacturing areas.
- Recognize, report, and escalate manufacturing incidents, equipment malfunctions, and safety concerns.
- Build productive and collaborative working relationships across departments and consistently demonstrate teamwork and professionalism.
- Follow all Piramal Pharma Solutions Safety, Health, Environmental, and Quality policies and procedures.
- Perform other duties as assigned to support business operations.
Education and Experience
- High School Diploma or GED required.
- Technical Trade School certification in Mechanical Technology, Industrial Maintenance, Mechatronics, or a related field preferred.
- In lieu of a technical certification, 3 to 5 years of mechanical experience in a manufacturing environment may be considered.
- Minimum of 3 years of experience operating, troubleshooting, maintaining, or repairing manufacturing or packaging equipment preferred.
- Experience in a pharmaceutical, biotechnology, chemical, food, or other regulated manufacturing environment required.
- Experience working within a cGMP-regulated environment preferred.
- Strong mechanical aptitude and troubleshooting skills.
Knowledge, Skills, and Abilities
- Knowledge of manufacturing and packaging equipment operation and maintenance.
- Ability to troubleshoot mechanical and operational equipment issues.
- Familiarity with cGMP regulations and documentation practices.
- Basic computer skills and ability to navigate electronic systems and training platforms.
- Ability to read and interpret SOPs, technical documents, and equipment manuals.
- Strong organizational, communication, and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced manufacturing environment.
Physical Requirements
- Ability to lift and move up to 45 pounds.
- Ability to work safely around manufacturing and packaging equipment.
- Frequent standing, walking, reaching, bending, and use of hands and fingers to operate tools and equipment.
- Ability to wear required Personal Protective Equipment (PPE).
- Visual acuity sufficient to operate equipment and inspect production processes.
- Ability to work in a manufacturing environment with exposure to chemicals, powders, and cleaning agents.
- Must be able to work safely in a regulated manufacturing environment.
Preferred Qualifications
- Experience with pharmaceutical packaging equipment and manufacturing equipment changeovers.
- Mechanical maintenance, industrial maintenance, or technical trade certification.
- Experience supporting investigations, deviations, and CAPA activities.
- Knowledge of Lean Manufacturing and continuous improvement principles.
