LL01-121025 HVAC Engineer
hace 10 días
Somerville
Job Description 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. Education: • 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)., • 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., • 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.