Job Description

• Project execution and management
• Continuous Improvement
• Analytical problem solving.

• Working in close collaboration with system owners, project teams, and cross-functional stakeholders
• Partner with system owners, maintenance, project management, and manufacturing to ensure reliable operation and execution of equipment and systems.
• Lead or support engineering-based improvements and capital projects, including requirements definition, design, construction, startup, and validation.
• Drive continuous improvement by applying Lean principles, Six Sigma, and other methodologies to reduce costs, improve quality/safety, and increase operational efficiency.
• Support commissioning, qualification, and performance verification activities for equipment and systems.
• Provide oversight into contractors and vendor deliverables and ensure adherence to company standards.
• Act as liaison between Engineering and Manufacturing during project planning, execution, and closeout.
• Provide technical root cause analysis, troubleshooting, and problem-solving support to minimize downtime.
• Support new product/technology introductions through engineering assessments and equipment modifications.
• Ensure compliance with environmental health, safety, and regulatory requirements during all engineering activities.
• Deliver coaching and guidance to project teams on commissioning, qualification, and process risk-based approaches.

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR associate’s degree and 8 years of experience OR High school diploma / GED and 10 years of experience

• Technical report writing, documentation, and presentations
• Strong verbal and written communication
• Organizational and change management skills
• Analytical problem-solving and scientific/engineering reasoning
• Experience with systems such as Maximo, TrackWise, E-Builder, PCS, BMS, and QEMS
• Ability to manage multiple projects and troubleshooting activities simultaneously
• Basic project management and cost estimation skills
• Conflict resolution and cross-functional collaboration
• Contractor and vendor management
• Development of SOPs and training delivery
• Customer service in a technical environment
• Continuous improvement methodologies (Lean, Six Sigma, SPC, Predictive Maintenance)

• Bachelor’s degree in chemical, Mechanical, Electrical, or related Engineering field
• 6+ years of relevant engineering experience, with at least 5+ years in a biopharmaceutical or regulated manufacturing environment
• Experience working in compliance-driven settings (e.g., cGMP, OSHA, EPA)
• Direct knowledge of design, operation, and troubleshooting of GMP production equipment (e.g., chemical reactors, chillers, tablet press, dosage, clean utilities, etc.)
• Demonstrated ability to apply engineering principles to system modifications, process improvements, and capital project execution
• Knowledge of safety requirements and quality systems in a biopharmaceutical environment (change control, deviations, CAPA, validation)
• Proven ability to lead and collaborate within cross-functional project teams
• Strong leadership, technical writing, and presentation skills
• Independent, self-motivated, organized, and able to adapt to dynamic project environments