QA-CSV Specialist - Execution Systems & Automation

Pauwels Consulting; Beerse; On-site; EUR 70,000 - 100,000; Full time

Job summary

Pauwels Consulting is seeking a highly qualified QA professional with a strong background in CSV, validation, and quality assurance within a GxP environment. The role emphasizes maintaining validated states, handling change control, and managing deviations to ensure compliance.

The successful candidate will bring hands-on experience with GMP guidelines (GAMP 5, EU GMP Annex 11, US FDA 21 CFR Part 11), along with familiarity with PLC and SCADA within manufacturing and automation settings.

Qualifications

• Bachelor or Master in engineering or related technical discipline.
• 4+ years in CSV/validation/QA in a GxP environment.
• Experience with change control, deviation management and maintenance of validated state.
• Knowledge of GAMP 5, EU GMP Annex 11 and US FDA 21 CFR Part 11.
• Experience with PLC and SCADA manufacturing/automation systems.
• Fluent in English.

Skills

CSV validation QA in GxP environments

Change control

Deviation management

Validated state maintenance

GAMP 5 knowledge

EU GMP Annex 11

US FDA 21 CFR Part 11

PLC systems

SCADA systems

English fluency

Education

Bachelor or Master in Engineering/Technical discipline

Tools

Active Directory

SIMATIC Logon

Industrial networks

Job description

• You have a Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences, or a related technical discipline.
• You bring 4+ years of relevant experience in CSV, validation, and quality assurance within a GxP environment.
• You possess experience in quality assurance including change control, deviation management, and maintenance of the validated state.
• You have a good working knowledge of GAMP 5, EU GMP Annex 11, and US FDA 21 CFR Part 11.
• You bring experience with manufacturing and automation systems such as PLC and SCADA.
• You're a solution-oriented communicator with the ability to challenge constructively in a collaborative environment.
• You are fluent in English.

Nice to Haves

• Experience with Active Directory, SIMATIC Logon, or industrial automation networks.
• Previous background in data-flow mapping and data integrity risk assessments.
• Knowledge of Dutch for local stakeholder interaction.