Project Engineer

Position Summary

Under general supervision, the Equipment / Reliability Engineer will support manufacturing operations by ensuring equipment reliability, optimizing maintenance strategies, and driving continuous improvement initiatives. This role will serve as a technical subject matter expert (SME) for manufacturing equipment, supporting troubleshooting, compliance, and performance optimization in a regulated environment.

Key Responsibilities

Equipment Ownership & Reliability

• Own manufacturing equipment within the CMMS system (work order approval/closure, PM strategy, spare parts management and updates)
• Develop and optimize preventive maintenance strategies to improve equipment performance
• Drive equipment reliability initiatives focused on increasing availability and reducing downtime
• Define and monitor equipment performance metrics (availability, downtime, MTBF, etc.)
• Identify and implement opportunities for equipment and process improvements

Operations Support

• Serve as SME for assigned equipment and systems (design, maintenance, compliance support)
• Support troubleshooting of manufacturing equipment and resolve operational issues
• Collaborate with cross-functional teams (Manufacturing, Maintenance, Engineering, Quality, Validation, Utilities, Facilities)
• Ensure compliance with cGMP, EHS, and regulatory requirements
• Participate in daily operations as needed to support production schedules

Quality & Compliance

• Support deviation investigations related to equipment issues
• Define, implement, and own CAPAs within area of responsibility
• Participate in change control assessments and implementation
• Ensure equipment and documentation are audit-ready at all times

Engineering & Projects

• Support process optimization and system improvement initiatives
• Lead or support equipment improvement and capital projects
• Assist in design modifications, installation, and qualification activities
• Review vendor proposals and support project cost estimates and scheduling

Qualifications

• Bachelor’s degree in Engineering with 2+ years of experience, or Master’s degree in Engineering
• Experience in equipment reliability, maintenance systems (CMMS), and asset management
• Strong troubleshooting and technical problem-solving skills
• Experience working in cGMP regulated environments
• Knowledge of change control, deviations, and CAPA systems
• Strong communication and documentation skills

Preferred Qualifications

• Experience in pharmaceutical or biotechnology manufacturing environments
• Familiarity with validation processes (IQ/OQ/PQ)
• Knowledge of aseptic operations (filling/support) – a plus
• Experience with process excellence or reliability engineering programs
• Familiarity with GLP, GMP, and data integrity principles

Core Competencies

• Analytical problem solving
• Technical troubleshooting and equipment expertise
• Process optimization
• Change management
• Technical report writing and documentation
• Strong organizational and computer skills

Additional Information

• Fully on-site role
• Ability to work in a fast-paced, highly regulated environment
• Other duties may be assigned as needed