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Senior Automation CSV Engineer (GMP)
53 500 - 85 445€
Описание вакансии
Текст:
TL;DR
Senior Automation CSV Engineer (GMP): Leading computerized system validation and qualification for automation, digital, and GMP-relevant systems across manufacturing, laboratory, utility, facility, and infrastructure environments with an accent on risk-based validation, data integrity, and lifecycle governance. Focus on developing inspection-ready documentation, managing deviations and CAPAs, supporting OT cybersecurity and change control, and coordinating cross-functional validation work across multiple projects.
Location: Leiden, South Holland, Netherlands
Base pay: €53,500–€85,445 per year
Company
Global healthcare organization developing medicines, medical technologies, and patient-focused healthcare solutions.
What you will do
- Lead computerized system validation and qualification across implementation, upgrades, requalification, periodic review, lifecycle changes, and retirement.
- Define risk-based validation strategies aligned with GAMP 5 and develop, review, and approve validation deliverables.
- Integrate data integrity standards into CSV workflows and support remediation of legacy systems.
- Manage automation system lifecycle governance, including inventories, configuration management, periodic reviews, change control, OT cybersecurity, and patching.
- Lead change impact assessments, deviation investigations, CAPAs, and inspection preparation for validated systems.
- Coordinate CSV scope, resources, workload, suppliers, and cross-functional stakeholders while coaching validation engineers.
Requirements
- Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, or a related discipline.
- At least 5 years of hands-on qualification and CSV experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
- Strong knowledge of cGMP, validation lifecycle principles, GAMP 5, data integrity, ALCOA+, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with GMP-relevant systems such as DeltaV, PLC, SCADA, and MES, including interfaces, electronic records, and data flows.
- Experience preparing validation documentation, risk assessments, protocols, reports, traceability, deviations, CAPAs, and change controls.
- Fluent written and spoken English is required.
Nice to have
- Experience supporting audits and regulatory inspections.
- Knowledge of OT cybersecurity practices such as ISA/IEC 62443.
- Experience with artificial intelligence, machine learning, robotic automation, project management, or lean supply chain management.
Culture & Benefits
- Initial 12-month contract with the intention to convert to a permanent contract.
- Annual bonus based on pay grade, location, and individual and company performance.
- Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and programs supporting financial, physical, and mental health.
- Insurance plans, service anniversary awards, and recognition programs subject to plan terms.