CSV Engineer (Pharma)

TL;DR

CSV Engineer (Pharma): Support operation and validation of automated systems within pharmaceutical GMP environment with an accent on CSV and SDLC methodologies for regulatory compliance. Focus on analyzing business requirements, integrating vendor-packaged equipment, and driving continuous improvement using LEAN principles.

Location: Hybrid • Boxmeer (Netherlands)

Salary: 75 000 - 80 000 EUR per year

Company

IT consultancy firm helping startups, mid-sized, and large corporations deliver innovative technologies including AI, ML, BI, Web, and Automation for industries like Pharma.

What you will do

• Support operation and validation of automated systems in pharmaceutical GMP environment.
• Apply CSV and SDLC methodologies to ensure compliance with regulatory and quality standards.
• Analyze business and process requirements to contribute to technical solutions.
• Integrate vendor-packaged equipment into site's digital and automation landscape.
• Collaborate with cross-functional teams on continuous improvement using LEAN/MPS/Six Sigma.
• Facilitate workshops, support decision-making, and contribute to validation documentation.

Requirements

• Bachelor's degree in Engineering, Computer Science, or technical discipline
• Experience with automated systems and automation fundamentals
• Strong knowledge of cGMP, CSV, and SDLC methodologies
• Excellent problem-solving, facilitation, and decision-making skills
• Ability to analyze business problems, build cases, and identify process/technology solutions
• Experience integrating vendor-packaged systems into digital manufacturing environment

Nice to have

• Experience with PLC/DCS commissioning in GMP pharmaceutical site
• Hands-on with Kneat electronic validation systems
• Participation in FAT activities at vendor sites