Staff R&D Engineer

360Pharma; Groningen; On-site; EUR 80,000 - 120,000; Full time

Job summary

360Pharma is seeking a Staff R&D Engineer to analyze product and process requirements, perform risk and root cause analysis, and drive development of designs, tests, and procedures. You will plan and execute validation/verification activities and support cGMP and ISO compliance.

You will lead technology transfer, mentoring multidisciplinary teams and coordinating with Operations, QA, and Regulatory Affairs to ensure robust, compliant processes.

Qualifications

• Bachelor's degree in Engineering or related field; 8+ years in a regulated industry.
• Master's degree preferred with 6+ years experience.
• Proven ability to manage technology transfer and oversee validation planning.

Responsibilities

• Analyze product and process requirements (materials, quality, EHS) and perform risk and root cause analysis.
• Develop and improve product designs, processes, equipment, test methods, and procedures; define technical requirements.
• Plan and execute validation and verification studies, including test plans, protocols, data analysis, and issue resolution.
• Lead technology transfer, validation planning, and project execution in Design Control.
• Provide strategic input and mentor team members; drive cross-functional collaboration with Operations, QA, and Regulatory Affairs.

Skills

Engineering leadership

Regulated industry experience

Minitab proficiency

English proficiency

Education

Bachelor's degree in Engineering or related field

Master's degree preferred

Tools

SolidWorks

Python

Matlab

Minitab

Microsoft Project

Job description

We are searching for the best talent for Staff R&D Engineer.

Responsibilities

You will be responsible for:

• Analyze product and process requirements (materials, quality, EHS) and perform risk and root cause analysis.
• Develop and improve product designs, processes, equipment, test methods, and procedures; define technical requirements.
• Plan and execute validation and verification studies, including test plans, protocols, data analysis, and issue resolution.
• Implement new or modified products and processes, author SOPs, protocols, risk assessments.
• Maintain compliance with cGMP, ISO standards; update procedures, support audits, and resolve CAPAs/NCRs.
• Provide strategic input and mentor team members.
• Drive cross-functional collaboration with Operations, QA, and Regulatory Affairs.
• Manage technology transfer, validation planning, and project execution.Lead planning and execution of complex development projects in compliance with Design Control.

Qualifications / Requirements

• Bachelor's degree in Engineering or related field with minimum 8 years of experience in a regulated industry.
• Master's degree preferred with minimum 6 years of experience.
• Proven ability to manage technology transfer and oversee validation planning.
• Experience providing strategic input and leading multidisciplinary projects.
• Advanced expertise in compliance, regulatory integration, and process optimization.
• Experience in mentoring teams and influencing project direction.
• Proficient in applying statistical methodologies and analysis using Minitab.
• Proficiency in English.

Preferred specific knowledge and skills

• Analysis of datasets using Python or MatLab.
• Designing 3D models using SolidWorks.
• Experience in rapid prototyping techniques using 3D printing.
• Proficient in the use of Microsoft Project.
• Six Sigma Certified Green Belt / Black Belt.
• Knowledge in high precision machining (lathing and milling).
• Knowledge in high precision injection molding.

Required Skills

Collaboration, Technical Credibility

Preferred Skills

Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection