Senior Commissioning, Qualification, and Validation (CQV) Engineer

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 https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Project Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, 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 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 a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our Team in Spring House, PA.

This position is part of the Site Engineering Team, which is the asset-management team consisting of Automation, Engineering/CQV and Maintenance for clinical labs, GxP warehouse operations, cell banking, and other GxP labs in Springhouse and Malvern, PA.

We are seeking a motivated and detail-oriented subject matter expert (SME) in CQV (Commissioning, Qualification, and Validation) to join our team.

The primary work location is in Spring House, PA, supporting the qualifications associated with a highly automated CAR-T Clinical Manufacturing facility, the future operation and asset life cycle management.

This may require supporting our other Large Molecule Clinical Production Site located in Malvern, PA.

Key Responsibilities:


* Ownership for the development and execution of the Project Validation Master Plan (PVMP)


* Support the writing and approval of URSs (User Requirement Specifications) for facilities, equipment and systems.


* Lead the writing and execution of Impact Assessments for equipment and facilities, IQ & OQ, and Re-qualification, as well as PQ activities


* Ensure flawless execution of Commissioning, Qualification, and Re-qualification works for manufacturing and laboratory equipment, execution systems, as well as facilities and utilities


* Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards


* Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure


* L...