Senior CSV Engineer

Blackfield Associates; Noord-Brabant; On-site; EUR 60,000 - 90,000; Full time

Job summary

Blackfield Associates is seeking a CSV Engineer to support GMP manufacturing site activities in the Netherlands. You will drive QA plans, validation protocols, and automation documentation, while coordinating with site teams on changes and commissioning efforts.

Responsibilities include equipment field testing, PLC/DCS upgrades, Kneat validation usage, and ensuring OEM SLAs. Strong problem solving and SDLC/Lean experience are essential.

Qualifications

• BS/BE in engineering or related technical field.
• Experience operating automated systems and understanding automation fundamentals.
• Strong knowledge of cGMPs, SDLC methodologies, and Lean/Sigma principles.
• Excellent facilitation, problem solving, and decision making skills.
• Ability to analyze business problems, build business cases, and identify solutions.
• Experience integrating vendor equipment into a site digital landscape.
• Experience commissioning PLC/DCS systems in GMP manufacturing.
• Kneat electronic validation system experience.

Responsibilities

• Prepare and approve quality assurance plans and close out reports.
• Partner with local site project teams to scope changes and prep documentation.
• Protocol generation, execution, and approval inside the electronic validation system.
• Review and approve automation documents.
• Field testing of equipment and support commissioning activities.
• Maintain inventory and upgrades to PLC/SCADA/DCS systems.
• Use development system as required.
• Ensure SLAs with OEM systems and back-up support.
• Build and maintain relationships with key OEM vendors for reliable supply.

Skills

Automation systems

cGMP knowledge

SDLC / Lean / Six Sigma

Problem solving

Vendor integration experience

PLC/DCS commissioning

Kneat electronic validation

Education

Bachelor's degree in Engineering or related field

Tools

Kneat eValidation

Job description

The CSV Engineer is responsible for activities that include the following:

• Prepare and approve Quality assurance plans and close out reports


• Partner with local site project teams to scope changes and prep relevant documentation


• Protocol Generation execution and approval inside the electronic validation system Review and approve automation documents


• Field testing Equipment and support commissioning


• Maintain Inventory and control upgrades to PLC/SCADA/DCS systems


• Use and update of development system if required


• Ensure SLA's are in place for OEM systems with appropriate support available as back-up if necessary


• Build and maintain relationships with key OEM vendors ensuring reliability of supply and cost effective support model

Partner with internal Digital departments ensuring standard and secure implementation in line with company standards .

Required:

• BS in Engineering, Computer Science, or other technical degree.


• Experience in operating automated systems understanding the automation fundamentals.


• Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles.


• Excellent facilitation, problem solving, and decision making skills.


• Demonstrated ability to analyze and define business problems, develop business cases, and identify appropriate process and technological solutions is essential


• Experience in integrating vendor packaged equipment into a site digital landscape.


• Experience in the commissioning of PLC/DCS's systems at a GMP manufacturing site.


• Kneat electronic validation system experience.