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Job Description
Job Title:
Pharmaceutical Engineering Manager - Oral Solid Dosage (OSD) Position Summary We are seeking an experienced Pharmaceutical Engineering Manager to lead engineering, maintenance, validation, and facility operations within a cGMP-regulated Oral Solid Dosage (OSD) manufacturing environment. The ideal candidate will possess extensive experience in OSD manufacturing engineering, facility engineering, equipment reliability, validation, and engineering team leadership. This role will be responsible for ensuring manufacturing equipment, utilities, facilities, and engineering systems operate safely, efficiently, and in compliance with regulatory requirements. Key Responsibilities Engineering & Manufacturing Operations Lead engineering activities supporting Oral Solid Dosage (OSD) manufacturing operations, including dispensing, granulation, blending, compression, coating, encapsulation, and packaging. Provide technical oversight for process improvements, equipment optimization, and capacity expansion projects. Drive continuous improvement initiatives to enhance productivity, equipment reliability, and operational efficiency. Support technology transfers, new product introductions, and process scale-up activities. Facility Engineering & Utilities Manage facility engineering operations including HVAC systems, clean utilities, compressed air, chilled water, purified water, dust collection systems, and environmental controls. Ensure facilities and utility systems remain compliant with regulatory and company requirements. Oversee facility upgrades, capital projects, and utility improvement initiatives. Monitor utility performance and implement preventive strategies to minimize downtime. Validation & Compliance Ensure compliance with FDA, cGMP, ICH, and other regulatory requirements. Lead equipment, utility, facility, and process validation activities. Review and approve
IQ/OQ/PQ
protocols, reports, change controls, deviations, CAPAs, and engineering documentation. Support internal audits, regulatory inspections, and customer audits. Maintain engineering documentation in accordance with GMP and data integrity requirements. Maintenance & Calibration Direct preventive maintenance, predictive maintenance, corrective maintenance, and calibration programs. Ensure optimal performance and reliability of manufacturing and utility equipment. Develop maintenance strategies to reduce downtime and improve asset utilization. Manage equipment lifecycle activities including procurement, installation, qualification, and retirement. Leadership & Team Management Lead, mentor, and develop engineering, maintenance, calibration, and facilities personnel. Establish departmental goals, KPIs, budgets, and resource plans. Foster a culture of safety, quality, accountability, and continuous improvement. Coordinate activities across Manufacturing, Quality Assurance, Validation, and Regulatory Affairs teams. Required Qualifications Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Industrial Engineering, or related discipline. 12+ years of pharmaceutical engineering experience within cGMP-regulated manufacturing environments. 12+ years of experience supporting Oral Solid Dosage (OSD) manufacturing operations. 12+ years of facility engineering experience including HVAC and clean utility systems. 12+ years of experience in cGMP compliance, validation, and regulatory requirements. 12+ years of equipment maintenance, reliability engineering, and calibration management experience. 12+ years of engineering leadership and people management experience
Pay:
$90,000.00 - $130,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance
