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