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Biocon · 2 weeks ago

Manager - Engineering & Maintenance

Cranbury, NJ

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Biocon is a leading biopharmaceutical company, and they are seeking a Manager - Engineering & Maintenance to oversee the maintenance of their OSD manufacturing equipment and ensure regulatory compliance. The role involves managing utilities and HVAC systems, leading safety programs, and maintaining documentation for audits.

BiopharmaBiotechnologyHealth CareMedical

Hiring Manager

Rekha Maddaraki

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

Qualification

OSD manufacturing experiencePreventive Maintenance programsRegulatory compliance knowledgeHVAC systems managementEquipment qualificationVendor managementSafety managementLeadership skillsProblem-solving skills