Process Equipment Engineer

Position Overview: The Process Equipment Engineer is responsible for supporting, designing, optimizing, and troubleshooting process equipment associated with DAP, Filling, CIP, and Formulation within a pharmaceutical facility. The role ensures compliance with cGMP, safety, and quality standards, providing technical expertise to ensure reliable operation and continuous improvement of process systems. Key Responsibilities: • Lead equipment qualification and validation activities for DAP, Filling, CIP, and Formulation systems. • Provide engineering support for daily operations, troubleshooting equipment and process-related issues to minimize downtime. • Collaborate with cross-functional teams (QA, Operations, Maintenance, Automation) for project execution and problem resolution. • Develop and review Standard Operating Procedures (SOPs), maintenance plans, and process recipes. • Participate in risk assessments, change controls, and investigations (deviations, root cause analysis). • Identify and drive improvement projects, including equipment upgrades, process optimization, and incorporation of new technologies. • Oversee installation, commissioning, and start-up of new or modified equipment. • Ensure equipment is compliant with regulatory and company standards including cGMP, EH&S, and FDA requirements. • Schedule and coordinate preventive maintenance, calibrations, and spare parts inventory. • Mentor and train technical staff on equipment operation, troubleshooting, and maintenance best practices. • Support audits and regulatory inspections as the Subject Matter Expert. • Maintain accurate engineering documentation (P&IDs, FDS, equipment data sheets, QC records). Minimum Requirements: • Bachelor’s Degree in Mechanical, Chemical, Bioprocess, or Industrial Engineering or related discipline. • 3+ years direct experience in process engineering within pharmaceutical manufacturing, focusing on aseptic processing, filling, CIP, and formulation. • Strong technical knowledge of process equipment (e.g., filling lines, mixers, CIP/COP systems, tanks, valves, pumps, sensors). • Familiarity with industry regulations: cGMP, FDA, EMA, and pharmaceutical validation standards. • Experience with equipment qualification (IQ/OQ/PQ) and process validation. • Proficiency in problem-solving methodologies (Root Cause Analysis, FMEA). • Working knowledge of automation, instrumentation, and controls preferred. • Excellent communication, project management, and teamwork skills.