Pharmaceutical Senior Manager - Engineering

Senior Manager, Engineering – Oral Solid Dosage (OSD) Manufacturing

Location: Chantilly, VA
Job Type: Full-Time
Experience: 12+ years

Job Overview

We are seeking an experienced Senior Manager, Engineering to lead engineering and facility operations at a pharmaceutical Oral Solid Dosage (OSD) manufacturing facility in Chantilly, VA.

The ideal candidate will have extensive hands-on experience in US-based pharmaceutical OSD manufacturing , with strong expertise in OSD production equipment, facility engineering, HVAC, cleanrooms, critical utilities, equipment reliability, maintenance, capital projects, and FDA cGMP compliance .

This role will provide technical and operational leadership across engineering, facilities, utilities, equipment reliability, and continuous improvement.

Key Responsibilities

• Lead engineering and facilities teams supporting OSD manufacturing, packaging, utilities, and facility systems.

• Provide technical leadership for equipment troubleshooting, optimization, reliability, and process improvements.

• Oversee installation, qualification, preventive maintenance, calibration, and maintenance of OSD manufacturing equipment.

• Support equipment including granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines .

• Lead root-cause investigations and implement CAPA for equipment and process-related issues.

• Manage HVAC systems, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and other critical utilities.

• Ensure facility environmental controls meet cGMP requirements for temperature, humidity, pressure differentials, and air quality.

• Develop and manage preventive maintenance and equipment reliability programs.

• Support facility expansions, renovations, infrastructure upgrades, and capital projects.

• Ensure engineering and facility operations comply with FDA cGMP, OSHA, environmental regulations, US building codes, and applicable regulatory requirements .

• Support audits, inspections, validation activities, change controls, and engineering documentation.

• Conduct and support risk assessments including FMEA and HAZOP .

• Drive continuous improvement initiatives using Lean, Six Sigma, and reliability engineering methodologies.

• Identify opportunities for automation, modernization, equipment optimization, and energy efficiency.

• Mentor and develop engineering and facilities personnel and build a high-performing engineering organization.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering , or a related field.

• 12+ years of engineering experience within pharmaceutical manufacturing.

• Significant direct experience in Oral Solid Dosage (OSD) manufacturing .

• Strong hands-on knowledge of OSD equipment including granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging equipment.

• Strong knowledge of facility engineering, HVAC, cleanrooms, clean utilities, compressed air, chilled water, boilers, vacuum systems, and environmental controls .

• Experience with preventive maintenance, equipment reliability, and calibration .

• Proven experience leading engineering and facilities teams.

• Strong understanding of FDA cGMP, validation, CAPA, change control, and regulatory compliance .

• Demonstrated experience working in US-based pharmaceutical manufacturing facilities and operations .

• Direct familiarity with US regulatory standards, OSHA requirements, local permitting, building codes, and FDA cGMP compliance is mandatory.

• Strong leadership, troubleshooting, project management, and communication skills.

Must-Have Requirements

• 12+ years of pharmaceutical engineering experience.

• Direct OSD manufacturing experience.

• Hands-on experience with OSD manufacturing equipment.

• Hands-on experience in US-based pharmaceutical facilities .

• Strong HVAC, cleanroom, utilities, and facility engineering knowledge.

• Engineering and facilities leadership experience.

• Strong FDA cGMP and US regulatory knowledge.

• Experience with equipment PM and calibration.

• US Citizen or Green Card Holder.

Note: Candidates without direct US pharmaceutical OSD manufacturing experience will not be considered.