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Client: Granules Pharmaceuticals, Inc. [Internal Field Only - Do Not Publish Externally]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

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