Senior Computer Systems Validation (CSV) Engineer
Antwerp
Digital - Infrastructure
Master
Work experience: 5-7
Reference number: 93150
Our client, a highly regulated organization operating in a GMP-controlled production environment, is preparing the commissioning of a new centralized manufacturing facility. To support this critical go-live, they are seeking a Senior Computer Systems Validation / IT Engineer to ensure that all IT and OT systems are compliant, validated, and fully audit-ready before the start of production.
The role combines hands-on implementation with validation leadership in a complex, compliance-driven context where accuracy, documentation discipline, and regulatory knowledge are essential.
Responsibilities:- Contribute to the design and implementation of the IT and OT environment supporting regulated production and quality control systems.
- Implement and configure infrastructure components, including identity management, security controls, virtualization, backup, and databases.
- Execute validation activities to achieve and maintain a validated state for computerized systems.
- Plan and perform upgrades, patching, change control, and periodic reviews in line with GMP requirements.
- Ensure compliance with applicable regulations, including EU GMP Annex 11 and FDA 21 CFR Part 11.
- Produce and maintain validation and operational documentation, including specifications, procedures, and SOPs.
- Support audits and inspections related to the IT environment and computerized installations.
What are we looking for?
- You have 8+ years of relevant experience in Computer Systems Validation (CSV) within GMP-regulated environments.
- You possess deep, hands-on knowledge of GMP legislation and compliance, which is a strict requirement for this role.
- You bring operational experience with Windows environments, Active Directory, and VMware.
- You have experience designing, documenting, and validating IT infrastructures in regulated production contexts.
- You are experienced in executing validation testing, change control, patch management, and periodic reviews.
- You bring practical knowledge of security best practices such as Microsoft Security Baseline and CIS Benchmarks.
- You hold a Master’s degree in a technical field or equivalent demonstrable experience.
- You are fluent in Dutch and English at a professional level.
- You're comfortable working in controlled environments where strict procedures and discipline are required.
Nice to Haves
- Experience with industrial automation environments such as PLC or SCADA systems.
- Exposure to the implementation of production or quality control installations in a GMP context.
- Experience working in highly audited or inspection-heavy environments.
What do we offer?
- Start date: ASAP
- Duration: 6–9 months, with possible extension
- Work regime: Part-time (minimum 4/5)
- Location: Mol
- Working model: Hybrid (up to 2 days remote per week)
- Contract: open to both permanent employees and freelancers
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