Associate Director, Engineering (Oral Solid Dosage))

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

• Bachelors 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 Were 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.