Pharmaceutical Senior Manager, Engineering

Senior Manager, Engineering – Oral Solid Dosage (OSD)

Job Type: Full-Time
Industry: Pharmaceutical Manufacturing
Function: Engineering / Facilities / Manufacturing
Experience: 12+ Years

Position Overview

We are seeking an experienced Senior Manager, Engineering to lead engineering and facility operations for a US-based Oral Solid Dosage (OSD) pharmaceutical manufacturing facility .

This role will oversee OSD manufacturing equipment, equipment reliability, facility engineering, utilities, maintenance, capital projects, validation, and continuous improvement , while ensuring compliance with cGMP, FDA, OSHA, safety, and applicable US regulatory requirements .

The ideal candidate will have strong hands-on experience in US pharmaceutical manufacturing facilities , particularly OSD operations, along with proven leadership experience managing engineering and facilities teams.

MUST-HAVE REQUIREMENTS

• 12+ years of engineering experience in pharmaceutical OSD manufacturing

• Strong hands-on experience supporting OSD manufacturing equipment

• Experience with equipment such as:

  • Granulators

  • Fluid Bed Dryers

  • Tablet Presses

  • Capsule Fillers

  • Coaters

  • Blenders

  • Packaging Lines

• Strong experience with equipment maintenance, preventive maintenance (PM), calibration, troubleshooting, qualification, and reliability

• Strong facility engineering experience, including:

  • HVAC

  • Cleanrooms

  • Compressed air

  • Chilled water

  • Boilers

  • Vacuum systems

  • Clean utilities

  • Building systems

  • Environmental controls

• Proven experience leading engineering and facilities teams

• Strong knowledge of cGMP, FDA requirements, validation, and pharmaceutical manufacturing regulations

• Hands-on experience in US-based pharmaceutical facilities and operations is mandatory

• Direct familiarity with US regulatory requirements, OSHA, local permitting, applicable building codes, and FDA cGMP compliance

Key ResponsibilitiesEngineering Leadership

• Lead engineering teams supporting OSD manufacturing, packaging, utilities, and facility systems.

• Provide technical direction for equipment troubleshooting, optimization, reliability, and process improvements.

• Develop long-term engineering and asset reliability strategies.

• Mentor and develop engineering and facilities personnel.

OSD Equipment & Manufacturing Support

• Oversee installation, qualification, maintenance, and optimization of OSD manufacturing equipment.

• Support granulation, drying, compression, encapsulation, coating, blending, and packaging operations.

• Ensure equipment operates reliably with minimal downtime.

• Lead root-cause investigations and implement appropriate CAPA.

• Manage preventive maintenance, calibration, and equipment reliability programs.

Facility Engineering & Utilities

• Oversee HVAC, cleanrooms, compressed air, chilled water, boilers, vacuum systems, clean utilities, and building systems.

• Ensure temperature, humidity, pressure differentials, air quality, and other environmental controls meet cGMP requirements.

• Manage preventive maintenance and facility reliability programs.

• Support facility expansions, renovations, capital projects, and infrastructure upgrades.

Compliance & Validation

• Ensure engineering and facility activities comply with cGMP, FDA, OSHA, and applicable US regulatory requirements .

• Support regulatory inspections and customer/internal audits.

• Maintain engineering documentation, change controls, qualification, and validation documentation.

• Support risk assessments including FMEA and HAZOP where applicable.

Continuous Improvement

• Drive initiatives to improve equipment reliability, reduce downtime, and improve manufacturing efficiency.

• Apply Lean, Six Sigma, and reliability engineering principles.

• Identify opportunities for automation, modernization, energy efficiency, and facility improvements.

Required Qualifications

• Bachelor's degree in Mechanical, Chemical, Electrical Engineering , or related discipline.

• 12+ years of pharmaceutical engineering experience , specifically in OSD manufacturing .

• Proven engineering/facilities leadership experience.

• Strong technical knowledge of OSD manufacturing equipment and facility infrastructure.

• Strong understanding of cGMP, FDA, validation, OSHA, and US pharmaceutical manufacturing requirements .

• Demonstrated experience working directly in US-based pharmaceutical manufacturing facilities .