Pharmaceutical Senior Manager, Engineering

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.

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

Responsibilities

• 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
• 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
• 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
• Ensure engineering and facility activities comply with cGMP, FDA, OSHA, and applicable US regulatory requirements; support regulatory inspections and audits; maintain engineering documentation, change controls, qualification, and validation documentation; support risk assessments including FMEA and HAZOP where applicable
• Drive continuous improvement 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

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

Skills

• Operations
• Utilities
• Manufacturing
• Maintenance
• OSD
• Pharmaceutical manufacturing
• Reliability
• OSHA
• Validation