Sr Engineering Manager - Pharma - Oral Dosage

Role : Senior Manager, Engineering (Oral Solid Dosage)

Domain : Pharmaceuticals/Biotechnology/Clinical Research

Job Type: Full Time

Location : USA - Chantilly

Experience: 10 - 25 Years

Position Overview: This role oversees equipment reliability, facility systems, utilities, capital projects, and continuous improvement initiatives while ensuring full compliance with cGMP, safety, and regulatory standards. The ideal candidate brings 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 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 such as granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, blenders, and packaging lines.
• Ensure equipment operates at peak performance with minimal downtime.
• Lead rootcause investigations and implement CAPA for equipment and process issues.
• Experience in PM and Calibration of the equipment.
• Facility Engineering & Utilities Management.
• Oversee 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 & Quality:

• Ensure all 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 & Risk Management:

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

Continuous Improvement:

• 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.

Team Development

Mentor and develop engineering and facility staff, fostering technical growth and leadership capability.

Build a collaborative, high performance engineering organization.

Must-Haves :

12+ years of engineering experience in pharmaceutical Oral Solid Dosage (OSD) manufacturing.

Deep technical knowledge of OSD equipment (granulators, fluid bed dryers, tablet presses, capsule fillers, coaters, packaging lines) and facility infrastructure (HVAC, cleanrooms, clean utilities, chilled water, boilers).

Demonstrated track record leading and developing larger engineering and facilities operations.

Candidates must have 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 is mandatory

Bachelor's degree in mechanical, Chemical, Electrical Engineering, or 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.