CSV Execution Lead: Automation & Validation Expert

Johnson Johnson

Leiden

On-site

EUR 90,000 - 130,000

Full time

4 days ago

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Job summary

Johnson & Johnson in Leiden seeks an experienced CSV Execution Lead to drive validation activities for automation, digital, and GMP-relevant systems across capital projects and day-to-day operations. You will plan, coordinate, and deliver validation work, coaching engineers and collaborating with multi-disciplinary teams to meet company standards.

The role covers modernized and legacy equipment, utilities, and facilities, with lifecycle management and inspection readiness as core

Qualifications

Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, or a related discipline.
5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment, including hands-on qualification and CSV work.
Strong knowledge of cGMP, validation lifecycle principles, GAMP 5, DI expectations, ALCOA+, EU GMP Annex 11, and 21 CFR Part 11.
Experience with GMP-relevant manufacturing, laboratory, or facility systems such as DeltaV, PLC, SCADA, and MES, including their interfaces, electronic records, and data flows.
Proven ability to develop, review, and approve qualification and validation documentation, including user requirements, risk assessments, protocols, reports, traceability, deviations, CAPAs, and change controls.
Proven ability to lead validation work across several projects at once and to coordinate cross-functional stakeholders and external suppliers.
Excellent communication, technical writing, and stakeholder management skills in a cross-functional, international environment.

Responsibilities

Leading CSV and qualification across the full system lifecycle, from implementation and upgrades through periodic review and retirement.
Defining risk-based validation strategies in line with GAMP 5, and developing, reviewing, and approving validation deliverables.
Integrating Data Integrity (DI) standards into CSV workflows, templates, and deliverables in partnership with the Data Integrity Lead, including supporting remediation of legacy systems.
Supporting lifecycle governance for automation systems, including the system inventory, configuration management, periodic reviews, and OT cybersecurity and patching under change control.
Leading change impact assessments, deviation investigations, and CAPAs for validated systems.
Keeping validation documentation inspection-ready, and acting as a main contact for validation topics during regulatory and third-party inspections.
Managing CSV scope, estimates, resources, and workload across projects, and maintaining the CSV work catalogue to drive standardization.
Partnering cross-functionally and coaching validation engineers on CSV and compliance, in line with the Johnson & Johnson Credo and Leadership Imperatives.