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Manager - Engineering & Maintenance
Manager - Engineering & MaintenanceBiocon • Cranbury, NJ, US
Manager - Engineering & Maintenance

Manager - Engineering & Maintenance

Biocon • Cranbury, NJ, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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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