Process Engineer - Vision

Get 360Pharma; Netherlands; On-site; EUR 60,000 - 90,000; Full time

Job summary

Get 360Pharma is seeking a Process Engineer to lead process engineering projects and continuous improvement for intraocular lens manufacturing in Groningen and across sites with similar processes.

You will drive process characterization, NPI changes, and productivity initiatives while collaborating with cross-functional teams to meet GMP and ISO standards.

Qualifications

• Bachelor's degree in Engineering or Material Science with 2+ years of relevant experience, or a Master's degree in Engineering with 2+ years of experience.
• Project management experience in an engineering environment.
• FDA-regulated environment experience preferred (2+ years).
• Six Sigma certification or extensive experience applying Six Sigma methodologies.

Responsibilities

• Provide technical leadership within a production value stream and own process improvements.
• Identify and implement equipment/process enhancements to improve efficiency, yield and safety.
• Plan and execute projects related to product and process improvement aligned with strategic goals.
• Design experiments using statistical tools to enhance manufacturing processes and product performance.
• Develop documentation for process validation, project management, and root cause analysis.

Skills

Data Analysis

Process Optimization

Validation Processes

Project management

Six Sigma

Education

Bachelor's degree in Engineering or Material Science

Master's degree in Engineering

Job description

Position Overview

The Process Engineer leads process engineering projects and continuous improvement initiatives supporting the manufacturing of intraocular lenses in Groningen and across other sites using the same processes. The role requires strong technical expertise and project management skills to drive process improvements, characterization activities, and design or NPI changes while collaborating with cross-functional teams. The engineer is responsible for problem identification, root cause analysis, project execution, reporting, financial analysis, support new product introduction and implementing productivity and efficiency improvements. Close collaboration with other departments, sites, and corporate functions is required to achieve quality, delivery, cost, and KPI objectives, all within GMP and ISO compliance.

Key Responsibilities

Responsible for providing technical leadership within a production value stream and have ownership for the following:

• Identify key opportunities to develop and implement equipment and/or process enhancements that will improve efficiency, product yield, and safety.


• Identify, plan, and implement projects related to product and process improvement, ensuring alignment with strategic goals.


• Design and implement experimental protocols applying statistical tools to enhance manufacturing processes and product performance.


• Analyze current processes to identify key opportunities for equipment and process enhancements that improve efficiency, yield, and safety.


• Develop detailed documentation for process validation, project management, business case proposals, and root cause problem solving while ensuring compliance with industry regulations and internal standards.


• Monitor and analyze production data to identify trends and provide actionable insights for continuous improvement.


• Lead Six Sigma initiatives to drive process optimization and problem resolution within production environments.


• Support NPI launch by completing process characterization work, process challenge testing, process capability and stability runs, to qualify new product & processes and achieve annual business plan.Engage with personnel in the identification and resolution of corrective/preventative actions that address any process quality related manufacturing issues.

Qualifications & Skills

Required Qualifications

• Bachelor's degree in Engineering or Material Science with 2+ years of relevant experience, or a Master's degree in Engineering with 2+ years of experience


• Project management experience in an engineering environment

Preferred Experience

• 2+ years of experience in an engineering role within an FDA-regulated environment


• Six Sigma certification or extensive experience applying Six Sigma methodologies for analytical problem solving

Required Skills: Data Analysis, Process Optimization, Validation Processes

Preferred Skills: Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy