Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

HVAC Engineer

The HVAC 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, and environmental controls to safeguard product quality, safety, and operational efficiency.

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.

Qualifications & Competencies

Education:

• 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.