Mechanical Engineer – GMP HVAC Systems

Johnson & Johnson Innovative Medicine•Raritan, NJ

17h•$94,000 - $151,800•Onsite

About The Position

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. 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.

Requirements

Minimum of a Bachelor’s degree required, focused degree in Mechanical Engineering, HVAC Technology, or related field preferred.
Minimum 6 years of HVAC engineering experience within manufacturing, biopharmaceutical, or industrial environments (Cell therapy is a plus)
Proven experience supporting aseptic environments (Grades A-D) and working within GxP frameworks.
Involvement in audits, inspections, and compliance activities with EMA, FDA, and other regulatory bodies.
Experience/knowledge in some of the following: HVAC system design, installation, maintenance, validation, and qualification
Experience with Building Management Systems (BMS) and Environmental Management Systems (EMS).
Experience in integrating data-driven technologies for system monitoring and decision-making.
Deep technical knowledge of HVAC systems, environmental controls, and cleanroom classifications.
Understanding of GxP, GMP, and regulatory standards.
Excellent problem-solving, analytical, and interpretative skills for HVAC drawings and manuals.
Knowledge of safety standards, environmental regulations, and best practices.
Strong communication, presentation, interpersonal skills and team collaboration.
Proven project management capabilities, emphasizing prioritization and proactive improvements.
Ability to create, review, and update SOPs, including HEPA filter programs, and serve as the SME for HEPA systems.

Nice To Haves

Knowledge of standards building codes, and environmental regulations.
Proficiency in data analytics, digital tools, and environmental monitoring systems.

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 systems and environmental controls, including the HEPA filter program.
Support the development and management of the HEPA program, including routine inspections, filter validation, and lifecycle management.
Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in daily interactions with the team.
Manage execution of additional improvements identified during engineering evaluations to enhance HVAC and BAS reliability.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year