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.