HVAC Engineer

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are currently seeking an HVAC Engineer who will be 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.

This is a 3 - 4 month contract position supporting ongoing site operations, compliance activities, and system improvement initiatives.

• 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.

• 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.
• 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.
• 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…