<p>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.</p> <p>We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:</p> <p>HVAC Engineer</p> <p>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.</p> <p>Key Responsibilities:</p> <ul> <li>Participate in the design, development, and implementation of HVAC systems and modifications to support site operations, including aseptic environments (Grades A-D). </li><li>Provide technical support for troubleshooting and resolving HVAC issues across the facility, ensuring compliance with GxP standards. </li><li>Support CQV activities related to HVAC systems. </li><li>Conduct inspections, testing, and maintenance of HVAC equipment and systems to ensure safety, efficiency, and regulatory compliance. </li><li>Support investigations related to HVAC systems, including root cause analysis and corrective actions, especially in aseptic and controlled environments. </li><li>Develop, review, and update HVAC system drawings, schematics, and technical documentation for projects and upgrades. </li><li>Lead or assist with HVAC risk assessments, hazard analyses, safety audits, and inspections to promote a safe and compliant working environment. </li><li>Collaborate with maintenance, automation, engineering, and operations teams to optimize HVAC systems, improve reliability, and maintain environmental controls in Grade A-D areas. </li><li>Develop maintenance programs for HVAC systems to enhance longevity and performance, with a focus on aseptic environments. </li><li>Support equipment validation, calibration, and qualification activities related to HVAC components, ensuring compliance with EMA, FDA, and other regulatory standards. </li><li>Ensure all HVAC activities adhere to regulatory requirements, industry best practices, and company policies, including EMA and FDA guidelines. </li><li>Provide training and technical guidance to site personnel on HVAC safety, procedures, aseptic environment controls, and GMP practices. </li><li>Manage HVAC projects from conception through execution, including vendor coordination and procurement, with attention to aseptic and GxP requirements. </li><li>Actively participate in GxP audits, inspections, and regulatory reviews to support the sites compliance efforts. </li><li>Foster a collaborative environment that promotes teamwork, continuous improvement, and adherence to regulatory standards. </li><li>Provide input to the business continuity program, anticipating asset-related risks that could impact operations. </li><li>Lead efforts to scope, plan, and implement HVAC system improvements, including procedures and systems. </li><li>Create and update SOPs related to HVAC systems and environmental controls, including the HEPA filter program. </li><li>Serve as the Subject Matter Expert (SME) for the HEPA filter program, ensuring compliance, proper maintenance, and performance validation. </li><li>Support the development and management of the HEPA program, including routine inspections, filter validation, and lifecycle management. </li><li>Understand and apply Johnson & Johnsons Credo and Leadership Imperatives in daily interactions with the team. </li></ul> <p>Qualifications & Competencies</p> <p>Education:</p> <ul> <li>Bachelors degree in Mechanical Engineering, HVAC Technology, or related field. </li></ul> <p>Experience:</p> <ul> <li>5+ years of HVAC engineering experience within manufacturing, biopharmaceutical, or industrial environments. </li><li>Proven experience supporting aseptic environments (Grades A-D) and working within GxP frameworks. </li><li>Involvement in audits, inspections, and compliance activities with EMA, FDA, and other regulatory bodies. </li><li>Knowledge of standards such as ASHRAE, NFPA, local building codes, and environmental regulations. </li><li>Experience in HVAC system design, installation, maintenance, validation, and qualification preferred. </li><li>Experience with Building Management Systems (BMS) and Environmental Management Systems (EMS). </li><li>Experience integrating data-driven technologies for system monitoring and decision-making. </li></ul> <p>Skills & Competencies:</p> <ul> <li>Deep technical knowledge of HVAC systems, environmental controls, and cleanroom classifications. </li><li>Strong understanding of GxP, GMP, and regulatory standards. </li><li>Proficiency in data analytics, digital tools, and environmental monitoring systems. </li><li>Excellent problem-solving, analytical, and interpretative skills for HVAC drawings and manuals. </li><li>Knowledge of safety standards, environmental regulations, and best practices. </li><li>Effective communicator with strong interpersonal skills and team collaboration. </li><li>Proven project management capabilities, emphasizing prioritization and proactive improvements. </li><li>Ability to create, review, and update SOPs, including HEPA filter programs, and serve as the SME for HEPA systems. </li></ul> <p>Working Conditions:</p> <ul> <li>Willingness to travel approximately 10% both nationally and internationally. </li><li>May involve standing for extended periods, sitting at a desk, climbing stairs, and light lifting of materials or equipment. </li><li>Work in areas with HVAC equipment, cleanrooms, and controlled environments, following strict safety and GMP protocols. </li><li>Flexibility to work outside regular hours, including evenings or weekends, to support maintenance, troubleshooting, or validation activities. </li></ul>