Manager CSV-Execution Automation Systems

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:
People Leader

All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

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.

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

Learn more and apply to this exciting new role!

The Automation Engineering Manager, Execution Systems CSV Lead drives the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices.

The incumbent is also accountable for the delivery and execution of the site's CSV strategy including projects and lifecycle management.

Key Responsibilities:


* Support the automation systems, configure interfaces, ensure compliance with global standards, write and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations.


* Ensure sound technical engineering concepts are applied in all tasks.


* Perform validation activities at the Site and ensures the approach and execution aligns to J&J expectations.

Scope includes IT, Execution Systems, and Laboratory Analytical systems.


* Understands industry-wide and Regulatory expectations for computer system validation and works with other members of IT and site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures.


* Provide input on improvement of life cycle documentation.

Provide input on SOP development.


* Act as a high-level technical resource for implementation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.


* Support the implementation and adoption of the global CSV program an...