LLHVAC Engineer

Overview

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to working under the highest ethics standards for the following position:

• HVAC Engineer

• Design, develop, and implement 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 GxP compliance.
• Support CQV activities related to HVAC systems.
• Inspect, test, and maintain HVAC equipment to ensure safety, efficiency, and regulatory compliance.
• Lead or assist with investigations related to HVAC systems, including root cause analysis and corrective actions 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, compliant working environment.
• Collaborate with maintenance, automation, engineering, and operations teams to optimize HVAC systems and environmental controls in Grade A–D areas.
• Develop maintenance programs for HVAC systems focusing on aseptic environments to enhance longevity and performance.
• Support equipment validation, calibration, and qualification activities related to HVAC components, ensuring compliance with EMA, FDA, and other standards.
• Ensure 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 controls, and GMP practices.
• Manage HVAC projects from conception to execution, including vendor coordination and procurement, with attention to aseptic and GxP requirements.
• 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.
• Develop and manage the HEPA program through routine inspections, filter validation, and lifecycle management.
• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in daily interactions with the team.

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

• 5+ years of HVAC engineering experience in 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 ASHRAE, NFPA, local building codes, and environmental regulations.
• Experience in HVAC system design, installation, maintenance, validation, and qualification.
• Experience with Building Management Systems (BMS) and Environmental Management Systems (EMS).
• Experience integrating data-driven technologies for system monitoring and decision-making.

• 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 and environmental regulations.
• Effective communicator with strong interpersonal skills and teamwork.
• Proven project management capabilities, prioritization, and proactive improvements.
• Ability to create, review, and update SOPs, including HEPA programs, and serve as SME for HEPA systems.

• Willingness to travel approximately 10% 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, clean rooms, 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.