Pinnaql ยท 1 day ago
HVAC Engineer
Raritan, NJ
Contract
Onsite
Senior Level
5+ years expPinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. The HVAC Engineer will be responsible for ensuring effective design, operation, and maintenance of HVAC systems in compliance with GxP standards and regulatory requirements.
Biotechnology
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
Demonstrate adherence to organizational values, leadership principles, and ethical standards in daily interactions with the team
Qualification
Required
Bachelor's degree in Mechanical Engineering, HVAC Technology, or a related field
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
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
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
Preferred
Experience in HVAC system design, installation, maintenance, validation, and qualification preferred
Experience with Building Management Systems (Client) and Environmental Management Systems (EMS)
Experience integrating data-driven technologies for system monitoring and decision-making
Company
Pinnaql
At Pinnaql we believe that different perspectives and backgrounds are what make a company flourish.
11-50 employees
H1B Sponsorship
Pinnaql has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Early StageRecent News
Company data provided by crunchbase