Biocon
Talent Acquisition and HRBP for Global Commercial
Responsibilities:
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.
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).
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.
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.
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.
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.
Seniority level Associate
Employment type Full-time
Job function Engineering and Manufacturing
Industries Pharmaceutical Manufacturing
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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.
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).
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.
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.
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.
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.
Seniority level Associate
Employment type Full-time
Job function Engineering and Manufacturing
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr