Manager / Sr Manager -Process Maintenance (Injectables) …, Telangana

Job Title: Manager / Sr. Manager Process Maintenance (Injectables) Location: Karakapatla (Manufacturing Facility) Department: Engineering / Maintenance Experience: 10–18 Years (preferred in sterile/injectable facilities) Job Summary: Responsible for ensuring reliable operation, maintenance, and continuous improvement of equipment and utilities used in injectable (sterile) manufacturing. The role focuses on minimizing downtime, ensuring regulatory compliance, and supporting uninterrupted production. Key Responsibilities: 1. Equipment & Process Maintenance
- Oversee preventive, predictive, and breakdown maintenance of injectable manufacturing equipment:
- Vial washing machines
- Sterilization tunnels
- Aseptic filling lines (vial/ampoule/PFS)
- Lyophilizers (freeze dryers)
- Autoclaves
- Ensure high equipment uptime and reliability. 2. Utilities Management
- Manage critical utilities systems:
- HVAC (classified cleanrooms)
- Water systems (PW, WFI loops)
- Clean steam, compressed air, nitrogen systems
- Ensure systems meet sterility and environmental compliance requirements. 3. Compliance & Documentation
- Ensure adherence to cGMP, USFDA, EU GMP, WHO guidelines.
- Handle deviations, CAPA, change controls, and audits.
- Maintain accurate documentation, logs, and SOPs. 4. Validation & Qualification Support
- Support IQ/OQ/PQ of equipment and utilities.
- Coordinate with QA/Validation teams for requalification activities.
- Participate in media fills and aseptic process validations. 5. Team Leadership
- Lead and mentor maintenance engineers and technicians.
- Plan manpower, shifts, and training programs.
- Drive a culture of safety, compliance, and continuous improvement. 6. Troubleshooting & Continuous Improvement
- Analyze recurring breakdowns and implement root cause analysis (RCA).
- Drive initiatives for OEE improvement and cost optimization.
- Implement energy-saving and efficiency projects. 7. Project & Vendor Management
- Manage installation and commissioning of recent equipment.
- Coordinate with vendors/AMC providers for specialized systems.
- Ensure timely execution of maintenance and capital projects. Required Qualifications:
- B.E / B.Tech in Mechanical / Electrical / Instrumentation Engineering
- 12–18 years of experience in pharmaceutical injectables/sterile manufacturing Required Skills:
- Strong knowledge of aseptic processing and sterile facility requirements
- Hands-on experience with injectable equipment and cleanroom utilities
- Deep understanding of GMP compliance and regulatory audits
- Expertise in troubleshooting complex equipment issues
- Strong leadership and cross-functional coordination skills Preferred Skills:
- Familiarity with SCADA / BMS systems
- Exposure to automation and digital maintenance systems
- Knowledge of EHS and risk management practices Key Competencies:
- Leadership & decision-making
- Problem-solving and analytical thinking
- Planning & execution excellence
- Attention to compliance and quality Regards Team Jodas expoim Pvt Ltd Apply on Kit Job: kitjob.in/job/4n5p63