Process Engineer

Job Title: Process Engineer Location: Richmond, IL Duration: Long Term Position Overview We are seeking a Process Engineer to support process validation, risk management, and engineering activities within a regulated manufacturing environment. This role will focus on validation execution, design documentation, risk assessments, process improvements, and cross-functional project coordination while ensuring compliance with quality and regulatory requirements. Key Responsibilities Lead and coordinate process validation activities, including IQ, OQ, and PQ execution. Develop, review, and maintain engineering and validation documentation. Author and review risk management documents, including Process FMEA (pFMEA). Support design transfer activities and process implementation projects. Coordinate with cross-functional teams on equipment installation and validation activities. Perform risk assessments and identify opportunities for process improvements. Support statistical analysis, Design of Experiments (DOE), and Test Method Validation (TMV) activities. Collaborate with Quality, Manufacturing, and Engineering teams to ensure project success. Ensure compliance with design controls, quality systems, and regulatory requirements. Required Qualifications Bachelor's Degree in Engineering or a related technical discipline. 2+ years of engineering experience within a regulated industry. Hands‑on experience with Process Validation (IQ/OQ/PQ). Experience with Risk Management methodologies, including FMEA. Knowledge of ISO 13485 and quality system requirements. Familiarity with design controls and engineering documentation. Understanding of statistical analysis, DOE, and validation principles is preferred. Proficiency with Microsoft Office applications. Strong problem‑solving, communication, and project coordination skills. #J-18808-Ljbffr Stark Pharma Solutions Inc