LL01-121025 HVAC Engineer

Validation & Engineering Group, Inc., a Pinnaql company, is a leading services supplier providing solutions to the pharmaceutical, biotechnology, chemical, food, and medical device industries across Laboratory, Compliance, Computer Systems, Engineering, Project Management, Validation, and related technical services.

We are seeking an HVAC Engineer to support a large aseptic pharmaceutical manufacturing campus in Raritan, NJ. This role is responsible for supporting the design, operation, troubleshooting, and lifecycle management of HVAC systems serving Grade A, B, C, and D classified environments, ensuring alignment with GxP requirements and environmental control strategies critical to sterile manufacturing operations.

This position is fully onsite and structured as an initial 3-month contract with strong potential to convert to a permanent, direct-hire role based on performance and business needs.

While candidates with HVAC system design experience in GMP-regulated environments are strongly preferred, the hiring team will also consider experienced pharmaceutical HVAC mechanics who have demonstrated ownership of classified-space systems, environmental monitoring performance, and aseptic facility support.

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.
• Support CQV activities related to HVAC systems.
• Conduct inspections, testing, and maintenance of HVAC equipment and systems to ensure safety, efficiency, and regulatory compliance.
• 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.
• Lead or assist with HVAC risk assessments, hazard analyses, safety audits, and inspections to promote a safe and compliant working environment.
• Collaborate with maintenance, automation, engineering, and operations teams to optimize HVAC systems, improve reliability, and maintain environmental controls in Grade A-D areas.
• 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.
• Ensure all HVAC activities adhere to regulatory requirements, industry best practices, and company policies, including EMA and FDA guidelines.
• Provide training and technical guidance to site personnel on HVAC safety, procedures, aseptic environment controls, and GMP practices.
• Manage HVAC projects from conception through execution, including vendor coordination and procurement, with attention to aseptic and GxP requirements.
• 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.
• Provide input to the business continuity program, anticipating asset-related risks that could impact operations.
• 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.
• Serve as the Subject Matter Expert (SME) for the HEPA filter program, ensuring compliance, proper maintenance, and performance validation.
• 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.

Education

Qualifications & Competencies

• Bachelor’s degree in Mechanical Engineering, HVAC Technology, or related field.

Experience

• 5 years of HVAC engineering experience within manufacturing, biopharmaceutical, or industrial environments.
• 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.
• Knowledge of standards such as ASHRAE, NFPA, local building codes, and environmental regulations.
• Experience in HVAC system design, installation, maintenance, validation, and qualification preferred.
• Experience with Building Management Systems (BMS) and Environmental Management Systems (EMS).
• Experience integrating data-driven technologies for system monitoring and decision-making.

Skills & Competencies

• Deep technical knowledge of HVAC systems, environmental controls, and cleanroom classifications.
• Strong understanding of GxP, GMP, and regulatory standards.
• Proficiency in data analytics, digital tools, and environmental monitoring systems.
• Excellent problem-solving, analytical, and interpretative skills for HVAC drawings and manuals.
• Knowledge of safety standards, environmental regulations, and best practices.
• Effective communicator with strong 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.

Working Conditions

• Willingness to travel approximately 10% both nationally and internationally.
• May involve standing for extended periods, sitting at a desk, climbing stairs, and light lifting of materials or equipment.
• Work in areas with HVAC equipment, cleanrooms, and controlled environments, following strict safety and GMP protocols.
• Flexibility to work outside regular hours, including evenings or weekends, to support maintenance, troubleshooting, or validation activities.