Senior Manager, Process Engineering

Job Description

Key Responsibilities: Equipment Design & Selection : Design and specify process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with the project goals and regulatory standards (e.g., GMP, FDA, EMA). Select appropriate equipment, considering factors such as material compatibility, process requirements, automation, and cost-effectiveness. Develop equipment specifications, datasheets, and technical documentation for procurement and installation. Having hands on experience for installing isolator-based filling line. Line manufacturer is Bausch + Straubel, Syntegon, Steriline. Project Execution & Management : Lead or support the execution of process equipment projects, including installation, commissioning, and qualification. Develop project plans, timelines, and budgets for equipment-related projects, ensuring the completion of all milestones on time and within scope. Coordinate with external vendors, suppliers, and contractors to ensure timely delivery and installation of process equipment. Oversee the installation and commissioning of new equipment and systems, ensuring smooth integration into existing operations. Qualification & Validation : Lead or support the qualification (IQ/OQ/PQ) and validation activities for process equipment to ensure it meets GMP and regulatory requirements. Ensure that all necessary documentation for equipment qualification, including protocols and reports, is completed and stored per regulatory requirements. Conduct risk assessments for equipment and identify potential failure modes or performance issues. Maintenance & Troubleshooting : Support the maintenance and troubleshooting of process equipment, addressing issues that arise during production or operations. Identify and implement continuous improvements to equipment reliability, performance, and lifecycle management. Develop maintenance schedules and ensure the timely servicing and calibration of critical equipment. Compliance & Documentation : Ensure that all equipment complies with the relevant industry standards, such as cGMP, FDA, EMA, and other local regulatory requirements. Maintain detailed technical documentation, including equipment manuals, maintenance records, and calibration logs. Review and update standard operating procedures (SOPs) for equipment operation and maintenance. Collaboration & Cross-Functional Work : Collaborate with process engineers, production teams, quality assurance, and regulatory teams to ensure equipment meets operational and regulatory requirements. Work closely with procurement teams to ensure proper specifications and sourcing of equipment. Training & Knowledge Sharing : Train operators and maintenance personnel on the proper use, maintenance, and troubleshooting of process equipment. Stay updated with the latest developments in pharmaceutical equipment technologies and industry best practices. Share knowledge and best practices with the team and mentor junior engineers.