Responsibilities

• Prepare, execute, and maintain validation documentation to ensure equipment, automated systems, and process improvements are properly qualified and validated prior to production implementation.
• Develop and evaluate validation strategies to support the efficient introduction of new equipment, technologies, and manufacturing processes.
• Create, update, and maintain technical documentation, including standard operating procedures (SOPs), process flow diagrams, engineering drawings, electrical schematics, equipment parameter lists, and control logic documentation.
• Ensure compliance with applicable regulatory requirements, quality standards, and internal policies.
• Support audits, inspections, and continuous improvement initiatives related to quality, compliance, and operational performance.
• Assist in the design, implementation, and optimization of automated manufacturing and production systems, including robotics, programmable logic controllers (PLCs), vision systems, motion control, and other automation technologies.
• Support capital equipment and automation projects from concept through installation, commissioning, validation, and production handoff.
• Provide hands-on technical support for equipment, manufacturing processes, troubleshooting, and process optimization as needed.
• Collaborate with cross-functional teams to improve efficiency, quality, reliability, and operational performance through automation and process improvements.
• Apply continuous improvement methodologies such as Lean Manufacturing, Six Sigma, Design for Manufacturability (DFM), and Design for Assembly (DFA).
• Analyze manufacturing processes, identify improvement opportunities, and implement corrective and preventive actions (CAPA) to address process, equipment, or quality issues.
• Review and approve validation protocols, test plans, reports, and related technical documentation, as appropriate for the role.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Industrial Technology, or a related technical field.
• Three to five years of experience in manufacturing, automation, process engineering, validation, or a related technical role.
• Experience with process validation, equipment qualification, automation systems, and technical documentation.
• Working knowledge of quality systems, manufacturing best practices, and applicable industry standards.
• Experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies is preferred.
• Strong analytical, problem-solving, organizational, and project management skills.
• Excellent written and verbal communication skills, with the ability to prepare technical reports and documentation.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Proficiency in English (reading, writing, and speaking); additional language skills are a plus.