Mechanical Engineer – GMP HVAC Systems

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:

Repair & Maintenance Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, 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 Mechanical Engineer – GMP HVAC Systems to join our team. This is an onsite position located in Raritan, NJ.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality and reliable supply of our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

Summary:

The Mechanical Engineer is responsible for ensuring the effective design, operation, and maintenance of HVAC systems across all site areas, including Grade A, B, C, and D environments, with a focus on aseptic conditions. The role supports GxP compliance, regulatory standards, a 24/7 manufacturing model and environmental controls to safeguard product quality, safety, and operational efficiency.

The CAR-T cGMP manufacturing facility is located in Raritan, NJ. The site consists of environmentally controlled cleanroom and support areas designed to enable aseptic drug product manufacturing. HVAC and mechanical engineering expertise, along with project management support, are required to enhance the performance, reliability, and control capabilities are required to maintain and optimize the air-handling units (AHUs) and building automation systems (BAS) supporting commercial operations.

Key Responsibilities:

• Participate in the design, development, and implementation of HVAC systems and modifications to support site operations, including aseptic environments (Grades A-D).

• Provide technical support for troubleshooting and resolving HVAC issues across the facility, ensuring compliance with GxP standards.

• Responsible for participation in any non-conformances related to equipment 

• Support investigations related to HVAC systems, including root cause analysis and corrective actions, especially in aseptic and controlled environments.

• Develop, review, and update HVAC system drawings, schematics, and technical documentation for projects and upgrades.

• Develop maintenance programs for HVAC systems to enhance longevity and performance, with a focus on aseptic environments.

• Support equipment validation, calibration, and qualification activities related to HVAC components, ensuring compliance with EMA, FDA, and other regulatory standards.

• Provide training and technical guidance to site personnel on HVAC safety, procedures, aseptic environment controls, and GMP practices.

• Actively participate in GxP audits, inspections, and regulatory reviews to support the site’s compliance efforts.

• Foster a collaborative environment that promotes teamwork, continuous improvement, and adherence to regulatory standards.

• Lead efforts to scope, plan, and implement HVAC system improvements, including procedures and systems.

• Create and update SOPs related to HVAC syste