Job Description
1. Equipment & Facility Maintenance
- Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers.
- Implement robust Preventive Maintenance (PM) and predictive maintenance programs.
- Conduct breakdown investigations and implement corrective actions.
- Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards.
2. Regulatory Compliance & Documentation
- Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements.
- Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs.
- Support internal and external audits (FDA, DEA, ISO, and customer audits).
3. Utilities & HVAC Systems Management
- Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems.
- Ensure qualified and compliant environmental controls for classified OSD manufacturing areas.
- Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems.
4. Equipment Qualification & Validation
- Work with Validation and QA teams on IQ/OQ/PQ protocols.
- Manage requalification schedules and ensure equipment remains in a validated state.
- Provide engineering assessments for change controls.
5. Safety, Risk Management & Compliance
- Ensure adherence to OSHA, NFPA, and site safety requirements.
- Implement safety programs including LOTO, confined space, hot work, and electrical safety.
- Conduct incident investigations and lead corrective actions.
6. Spare Parts & Vendor Management
- Maintain optimum inventory of critical spare parts.
- Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs.
- Evaluate and onboard modern technologies and suppliers.
Qualifications & Experience
Education:
- Bachelor’s degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent).
- Preferred: Master’s degree or certifications such as CMRP or PMP.
Experience:
- 8–15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing.
- Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems.
- Experience with FDA/DEA audits and equipment validation.
Must have a valid work permit.
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