Associate Director, Engineering (Oral Solid Dosage)

Position Overview

We are seeking an experienced and highly motivated Associate Director, Engineering (Oral Solid Dosage) to lead engineering and facility operations within an Oral Solid Dosage (OSD) pharmaceutical manufacturing environment.

This role is responsible for equipment reliability, facility systems, utilities, capital projects, and continuous improvement initiatives while ensuring compliance with cGMP, safety, quality, and regulatory requirements.

The ideal candidate brings strong technical expertise in OSD manufacturing processes along with extensive knowledge of facility engineering, including HVAC, clean utilities, building systems, and environmental controls.

Key Responsibilities

Engineering Leadership

Lead and manage engineering teams supporting OSD manufacturing, packaging, utilities, and facility systems.
Provide technical direction for equipment troubleshooting, optimization, reliability, and process improvements.
Develop and execute long-term engineering strategies that support operational excellence and asset reliability.
Establish effective maintenance, reliability, and engineering practices across manufacturing and facility operations.

OSD Equipment & Process Support

Oversee the installation, qualification, maintenance, and optimization of OSD manufacturing equipment, including:
- Granulators
- Fluid bed dryers
- Tablet presses
- Capsule fillers
- Coaters
- Blenders
- Packaging lines
Ensure equipment operates reliably and efficiently while minimizing downtime.
Lead root-cause investigations for equipment and process issues.
Implement corrective and preventive actions (CAPA) to address recurring issues.
Oversee preventive maintenance (PM) and calibration programs for manufacturing equipment.
Support equipment upgrades, modifications, and technology improvements.

Facility Engineering & Utilities

Oversee the operation and maintenance of critical facility systems and utilities, including:
- HVAC systems
- Cleanrooms
- Compressed air
- Chilled water
- Boilers
- Vacuum systems
- Building management systems
- Other critical manufacturing 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 facility systems operate safely, reliably, and efficiently.
Identify opportunities to improve energy efficiency and optimize facility performance.

Compliance & Quality

Ensure engineering and facility operations comply with applicable cGMP, FDA, EU, quality, and regulatory requirements.
Support regulatory inspections, quality audits, and engineering-related assessments.
Maintain accurate engineering documentation and records.
Manage engineering change controls and support qualification and validation activities.
Ensure equipment and facility systems remain in a validated and compliant state.

Safety & Risk Management

Promote a strong safety culture across engineering and operations.
Conduct engineering and operational risk assessments, including FMEA and HAZOP where appropriate.
Implement engineering controls and mitigation strategies to reduce operational and process risks.
Ensure facility systems and engineering activities meet applicable safety and environmental requirements.

Continuous Improvement

Lead initiatives to improve equipment reliability, reduce downtime, and increase manufacturing efficiency.
Apply Lean, Six Sigma, and reliability engineering methodologies to engineering and manufacturing challenges.
Identify opportunities for automation, modernization, and process optimization.
Develop and implement strategies to improve asset performance and overall operational effectiveness.

Team Development

Mentor and develop engineering and facility personnel.
Build technical capabilities and leadership skills within the engineering organization.
Foster a collaborative, accountable, and high-performing team environment.
Establish clear performance expectations and promote continuous technical development.

Required Qualifications

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, or a related engineering discipline.
12+ years of engineering experience within pharmaceutical OSD manufacturing.
Strong knowledge of pharmaceutical manufacturing equipment and OSD processes.
Extensive experience with facility engineering, including:
- HVAC
- Clean utilities
- Building systems
- Environmental controls
- Critical manufacturing utilities
Proven experience leading engineering and facility teams.
Strong understanding of cGMP, equipment qualification, validation, maintenance, and regulatory requirements.
Experience with preventive maintenance and calibration programs.
Strong troubleshooting, root-cause analysis, and problem-solving skills.
Experience supporting capital projects, facility modifications, and equipment upgrades.
Strong understanding of safety, risk management, and regulatory compliance.

Preferred Experience

Experience implementing Lean, Six Sigma, or reliability engineering programs.
Experience with automation and manufacturing technology modernization.
Experience managing large-scale engineering or facility improvement projects.
Experience working in highly regulated pharmaceutical manufacturing environments.
Strong leadership, communication, and stakeholder management skills.

What We're Looking For

The successful candidate will be a technically strong engineering leader who can balance day-to-day operational reliability with long-term engineering strategy.

You should be comfortable working across manufacturing equipment, facility systems, utilities, compliance, capital projects, and continuous improvement while developing and leading a high-performing engineering organization.

Associate Director, Engineering (Oral S...