Full Job Description
We are seeking an experienced Engineering Manager – Oral Solid Dosage (OSD) to lead engineering, facilities, maintenance, and technical operations for a pharmaceutical manufacturing facility. The ideal candidate will have 12+ years of engineering experience within pharmaceutical OSD manufacturing, with strong hands-on expertise in OSD production equipment, facility infrastructure, utilities, regulatory compliance, and engineering operations.
This role will provide technical leadership for manufacturing equipment, facility systems, capital projects, reliability initiatives, maintenance operations, and continuous improvement while ensuring compliance with FDA cGMP, OSHA, applicable building codes, and US regulatory requirements.
Key Responsibilities
Lead and develop engineering, facilities, maintenance, and technical operations teams supporting pharmaceutical OSD manufacturing.
Provide technical oversight for OSD manufacturing equipment, including:
High-shear and wet granulators
Fluid bed dryers
Tablet presses
Capsule filling machines
Coating systems
Bottle and solid-dose packaging lines
Manage facility infrastructure and critical utilities, including HVAC, cleanrooms, chilled water systems, boilers, compressed air, purified water, and other clean utilities.
Develop and execute preventive and predictive maintenance programs to improve equipment reliability, uptime, and operational efficiency.
Lead troubleshooting, root-cause analysis, equipment reliability, and corrective action initiatives.
Manage engineering projects, equipment installations, facility expansions, modifications, and capital improvement projects from concept through commissioning and qualification.
Partner closely with Manufacturing, Quality, Validation, EHS, Supply Chain, and Operations to resolve technical issues and support production goals.
Ensure engineering and facilities systems remain compliant with FDA cGMP and applicable US regulatory requirements.
Maintain compliance with OSHA regulations, local permitting requirements, building codes, fire/life-safety requirements, and environmental regulations.
Support inspections, audits, investigations, CAPA, change controls, and regulatory commitments related to engineering and facility systems.
Establish engineering standards, SOPs, maintenance procedures, and technical documentation.
Manage engineering budgets, contractors, vendors, service providers, and capital expenditures.
Evaluate equipment and facility performance and identify opportunities for automation, modernization, energy efficiency, and cost reduction.
Lead and mentor engineering and facilities personnel, establishing performance expectations and developing technical talent.
Ensure engineering activities are executed safely, efficiently, and in accordance with company quality and compliance standards.
Required Qualifications
Bachelor’s degree in Mechanical, Electrical, Chemical, Industrial Engineering, or a related engineering discipline.
12+ years of engineering experience in pharmaceutical OSD manufacturing.
Strong hands-on knowledge of OSD manufacturing equipment and processes.
Proven experience with granulators, fluid bed dryers, tablet presses, capsule fillers, coating equipment, and packaging lines.
Strong understanding of pharmaceutical facility infrastructure, including HVAC, cleanrooms, chilled water, boilers, compressed air, and clean utilities.
Demonstrated track record leading and developing large engineering, facilities, and maintenance teams.
Strong hands-on experience working in US-based pharmaceutical facilities is mandatory.
Direct knowledge of US FDA cGMP requirements, OSHA regulations, building codes, local permitting, and facility compliance requirements.
Experience managing engineering projects, equipment installations, commissioning, qualification, and facility modifications.
Strong troubleshooting, problem-solving, project management, and leadership skills.
Excellent communication and cross-functional collaboration abilities.
Pay: $120,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Paid time off
Work Location: On the road
