Associate Director, Engineering Senior Manager, Engineering

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Client: Granules Pharmaceuticals Inc. Internal Field Only - Do Not Publish Externally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: Bachelors 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