Associate Director, Engineering (OSD) / Senior Manager, Engineering
venturatalentsChantilly (VA)
Associate Director, Engineering (OSD) / Senior Manager, Engineering
Posted today
venturatalentsChantilly (VA)
SENIORITY
Manager
About the role
Job Description Job Description Job Type: Full Time
Department: Engineering / Facilities
Industry: Pharmaceuticals / Biotechnology / Clinical Research
Openings: 1
Visa Status: US Citizen, Green Card, H1B Transfer
Client:
Granules Pharmaceuticals, Inc. [Internal Field Only - Do Not Publish Externally]
=== JOB DESCRIPTION ===
About the Company:
Granules Pharmaceuticals, Inc., a subsidiary of Granules India Ltd., is a vertically integrated pharmaceutical company with a strong global presence. We are expanding our OSD manufacturing operations in Chantilly, VA.
Position Overview:
We are seeking an experienced and highly motivated Associate Director / Senior Manager of Engineering to lead all engineering and facility operations within our Oral Solid Dosage (OSD) manufacturing site. This critical leadership role oversees equipment reliability, facility systems, utilities, capital projects, and continuous improvement initiatives while ensuring full compliance with cGMP, safety, and regulatory standards.
This position will oversee approximately 31 employees (20 at GPI and 11 at GCH) once fully staffed, making proven large-team leadership essential.
Key Responsibilities:
Engineering Leadership:
Lead and manage engineering teams supporting OSD manufacturing, packaging, utilities, and facility systems
Provide technical direction for troubleshooting, equipment optimization, and process improvements
Develop long-term engineering strategies that support operational excellence and asset reliability
OSD Equipment & Process Support:
Oversee installation, qualification, and maintenance of OSD equipment: granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines
Ensure equipment operates at peak performance with minimal downtime
Lead root-cause investigations and implement CAPA for equipment and process issues
Own PM and Calibration programs for equipment
Facility Engineering & Utilities Management:
Oversee operation and maintenance of critical systems: HVAC, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and clean utilities
Ensure environmental controls meet cGMP requirements for temperature, humidity, pressure differentials, and air quality
Manage facility maintenance programs, preventive maintenance schedules, and reliability initiatives
Support facility expansions, renovations, and infrastructure upgrades
Ensure compliance with OSHA, environmental regulations, and internal safety standards
Compliance & Quality:
Ensure all engineering and facility operations comply with cGMP, FDA, EU, and internal quality standards
Support audits, inspections, documentation, change controls, and validation protocols
Safety & Risk Management:
Champion strong safety culture across engineering and operations
Conduct risk assessments (FMEA, HAZOP) and implement engineering controls
Continuous Improvement & Team Development:
Drive initiatives to improve equipment reliability, reduce downtime, and enhance process efficiency
Implement Lean, Six Sigma, and reliability engineering methodologies
Identify opportunities for automation, modernization, and energy efficiency
Mentor and develop engineering and facility staff, fostering a high-performance culture
=== REQUIREMENTS ===
Education:
Bachelor's degree in Mechanical, Chemical, Electrical Engineering, or related field
Experience:
7+ years minimum (12+ years preferred) of engineering experience in pharmaceutical Oral Solid Dosage (OSD) manufacturing - MANDATORY
Deep technical knowledge of OSD equipment: granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, packaging lines
Deep knowledge of facility infrastructure: HVAC, cleanrooms, clean utilities, chilled water, boilers, compressed air, vacuum systems
Demonstrated track record leading and developing larger engineering and facilities operations (30+ staff total, multi-site preferred)
Strong, hands-on experience in US-based facilities and operations
Direct familiarity with US regulatory standards, local permitting requirements, building codes, OSHA regulations, and FDA cGMP compliance - MANDATORY
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