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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