Staff R&D Engineer: Process Innovation & Validation Lead

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

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.