Senior Automation CSV Engineer

Johnson Johnson; Leiden; On-site; EUR 90,000 - 130,000; Full time

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.

Skills

Analytical thinking

Problem solving

Communication

Stakeholder management

Education

Bachelor's or Master's degree in Engineering/Automation/CS/IT/Life Sciences

Tools

DeltaV

PLC

SCADA

MES

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Engineering

Job Sub Function

Automation Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Leiden, South Holland, Netherlands

Job Description

We offer an initial 12-month contract with the intention to convert to a permanent contract.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Computerized System Validation (CSV) Execution Lead.

Purpose

The CSV Execution Lead leads validation and qualification activities for automation, digital, and GMP-relevant systems across capital projects and day-to-day operations. The scope covers modernized and legacy manufacturing equipment, laboratory equipment, utilities, facilities, infrastructure, and computerized systems. The work spans new implementations, upgrades, re-qualifications, lifecycle changes, periodic reviews, and inspection preparation.

As the Automation SME for CSV, this person plans, coordinates, and delivers validation work. They also coach validation engineers and act as a core or extended team member on projects. The role works closely with Engineering, Quality, Manufacturing, C&Q, IT, and project teams. Together, they make sure systems are delivered and maintained in line with company standards, regulatory requirements, and industry best practice.

You will be responsible for

• 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.

Qualifications / Requirements

Required

• 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.
• Strong analytical, risk-based, problem-solving, and root cause analysis skills, with the ability to make sound and defensible decisions.
• Excellent communication, technical writing, and stakeholder management skills in a cross-functional, international envi