Senior Automation CSV Engineer

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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, includ...