Associate Director, Engineering (Oral Solid Dosage)

Employment type: Full-time (1 position)
Experience: 10–25 years

Position Overview

We are seeking an experienced and highly motivated engineering leader to oversee engineering and facility operations at an Oral Solid Dosage (OSD) manufacturing site. This role covers equipment reliability, facility systems, utilities, capital projects, and continuous improvement while ensuring compliance with cGMP, safety, and regulatory standards. The ideal candidate has deep technical expertise in OSD processes and strong knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.

Key Responsibilities

Engineering Leadership

• Lead 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 to support operational excellence and asset reliability.

OSD Equipment and Process Support

• Oversee installation, qualification, and maintenance of OSD equipment, such as granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines.
• Ensure equipment operates reliably with minimal downtime.
• Lead root-cause investigations and implement corrective and preventive actions (CAPA) for equipment and process issues.
• Manage preventive maintenance and equipment calibration.

Facility Engineering and Utilities Management

• Oversee the operation and maintenance of HVAC systems, cleanrooms, compressed air, chilled water, boilers, vacuum systems, and other critical 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 and Quality

• Ensure engineering and facility operations comply with cGMP, FDA, EU, and internal quality standards.
• Support audits, inspections, and documentation requirements.
• Maintain engineering documentation, change controls, and validation protocols.

Safety and Risk Management

• Promote a strong safety culture across engineering and operations.
• Conduct risk assessments (FMEA, HAZOP) and implement engineering controls to support safe operations.
• Ensure facility systems meet safety, environmental, and regulatory requirements.

Continuous Improvement

• Lead initiatives to improve equipment reliability, reduce downtime, and enhance process efficiency.
• Apply Lean, Six Sigma, and reliability engineering methodologies.
• Identify opportunities for automation, modernization, and energy efficiency.

Team Development

• Mentor and develop engineering and facility staff, supporting their technical growth and leadership capabilities.
• Build a collaborative, high-performing engineering organization.

Qualifications

• Bachelor’s degree in mechanical, chemical, or electrical engineering, or a related field.
• 12+ years of engineering experience in pharmaceutical OSD manufacturing.
• Strong knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.
• Proven leadership experience managing engineering and facility teams.
• Deep understanding of cGMP, validation, and regulatory requirements.