Extrusion Engineer

Job Title:
Extrusion Engineer

The Extrusion Engineer is responsible for the startup, troubleshooting, planning, execution, and documentation of validation activities for a multi-layer cast extrusion line. This role ensures compliance with regulatory standards and internal quality requirements, while playing a critical role in supporting the development, training, and handover of extrusion equipment to the laboratory.

• Coordinate with equipment vendors, maintenance, facilities, and controls engineers during startup.
• Verify that utilities such as power, water, air, vacuum, and resin handling are correctly connected and meet specifications.
• Review and approve machine setup, alignment, and safety interlocks.
• Ensure the machine is installed according to OEM documentation and internal engineering standards.
• Develop initial process parameters including temperatures, screw speeds, pressures, and puller speeds.
• Conduct structured trials to establish stable, repeatable extrusion conditions.
• Optimize throughput, melt quality, dimensional stability, and scrap rate.
• Identify and mitigate process bottlenecks or mechanical issues early.
• Document process windows and establish centerlines for production.
• Configure machine recipes, alarms, and control logic.
• Verify sensors, heaters, drives, and feedback loops operate correctly.
• Develop and execute validation protocols (IQ/OQ/PQ) for laboratory instruments, equipment, and systems.
• Collaborate with cross-functional teams including Quality Assurance, R&D, and IT to ensure validation activities align with project timelines and regulatory expectations.
• Author and review validation documentation including risk assessments, validation plans, reports, and SOPs.
• Ensure compliance with regulatory requirements such as GxP guidelines.
• Maintain validation lifecycle documentation and change control records.
• Participate in continuous improvement initiatives to enhance validation processes and efficiency.
• Identify and resolve issues related to equipment functionality during validation processes.
• Provide guidance and training to laboratory staff on validation procedures and equipment use.
• Develop or update SOPs, work instructions, and process control plans.
• Define critical quality attributes (CQA) and critical process parameters (CPP).
• Train quality technicians on inspection methods specific to the new line.
• Ensure traceability and documentation meet regulatory or customer requirements.
• Train operators on machine operation, startup/shutdown, troubleshooting, and safety.
• Train staff on safe operation and emergency procedures.
• Provide maintenance with preventive maintenance schedules and spare‑parts lists.
• Create troubleshooting guides and other documentation.
• Support initial production runs until the line is stable and operators are confident.

• Extensive hands‑on experience operating and executing validation activities on multi‑layer cast extrusion line equipment.
• Strong documentation and communication skills.
• Understanding of regulatory and quality requirements and common validation procedures.
• Safety and compliance oriented with a degree in Engineering, Life Sciences, Chemistry, or a related field.
• 10+ years of relevant experience in extrusion including validation within a scientific or regulated industry.
• Strong understanding of regulatory requirements (GxP).
• Previous experience in equipment validation, particularly IQ/OQ/PQ processes, within a regulated environment (e.g., pharmaceutical, biotech).
• Excellent technical writing, documentation, and communication skills.
• Proficiency in Microsoft Office and validation management systems.
• Ability to manage multiple projects and priorities in a fast‑paced environment.

• Strong teamwork skills for coordinating with various departments like Quality Assurance, Laboratory Operations, and Facilities.
• Proficiency in tackling challenges and identifying solutions during validation processes.
• Ability to clearly articulate technical details to diverse stakeholders, both verbally and through documentation.
• Meticulousness in documenting and executing validation protocols to ensure compliance.
• Effective…