Validation Engineer (CSV)

Location: Geel, Belgium

Company

hirify.global is an independent technology consulting firm providing technology guidance and solutions through its Information System & Digital, Telecom, Life Sciences, and Engineering business lines.

What you will do

• Plan, develop, implement, and execute validation activities for cGMP-critical software packages and computerized systems.
• Prepare, review, approve, and maintain validation protocols, reports, and related documentation.
• Perform hands-on validation activities including URS, SIA, DQ, IQ, OQ, PQ, RV, and TM.
• Assess changes for their impact on validated status and define required validation activities.
• Investigate validation and system issues, troubleshoot root causes, and implement corrective actions.
• Provide technical input on cGMP, cGLP, US FDA, EU, and internal regulatory requirements while collaborating with QA, IT, engineering, and business stakeholders.

Requirements

• At least 3 years of experience in the pharmaceutical sector and a GMP environment.
• Solid knowledge of Computer Systems Validation and quality and compliance regulations, including GxP, data integrity, and FDA/EU guidelines.
• Experience validating software packages and computerized systems from planning through execution and documentation.
• Strong troubleshooting, independent working, learning, and project execution skills.
• Strong communication skills for collaboration with QA, IT, engineering, and business stakeholders.
• Good spoken and written English and Dutch are required.

Culture & Benefits

• Long-term projects averaging more than 18 months with major accounts and support from internal Centers of Excellence.
• Structured management support, regular project check-ins, and monthly access to HR.
• Functional and geographic mobility opportunities across four areas of expertise and more than 60 countries.
• Access to training modules, fully funded Microsoft certifications, and in-house AI initiatives.
• Benefits include health insurance, remote work, meal vouchers, a time savings account, and a referral bonus.

Hiring process

• Brief virtual or phone call.
• Approximately three interviews, depending on the seniority required.
• Potential case study, technical assessment, role play, or problem-solving test.