Title: Senior Process Engineer

Summary:

• The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives.
• Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level.
• Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility.
• Flexible to support second shift when needed to ensure the project's critical timeline is maintained.

Major Accountability:

• Guide and supervise onsite installation and commissioning activities of equipment/system.
• Install subsystems owned by the Client in production line.
• Implement equipment optimizations and modifications.
• Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
• Lead complex root cause investigations.
• Performs change assessments.
• Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.
• Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
• Second line escalation in case of equipment failures.
• Driving continuous improvement from an asset perspective.
• Reducing safety risks through simplification and error proofing machines.
• Improving equipment reliability through equipment design modifications.
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
• Set-up maintenance for new equipment (incl. spare part needs).
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals.
• Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
• Perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems.
• Support internal and external audits.
• Provide technical trouble shooting during Startup, PQ and validation activities.
• Develop periodic requalification plan.
• Execute periodic requalification plan.
• Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities.
• Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
• Write/revise accurate engineering documents for various production system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs.
• Complete and provide accurate documentation, as required in cGMP operations.
• Use of CMMS system for documentation of relevant work.
• Other related duties as assigned.​