Site Mechanical & HVAC Engineer

$121,300 - $181,900/Yr

Spark Therapeutics - Philadelphia, PA

Full-time - Mid Level

Philadelphia, PA

Ambulatory Health Care Services

About the position

The Site Mechanical & HVAC Engineer at Spark Therapeutics plays a crucial role in providing technical engineering support and oversight for GxP and Non-GxP Mechanical and HVAC systems. This position involves engineering support for the design and implementation of new equipment and system modifications, as well as supporting CAPEX projects and troubleshooting operational issues. The engineer will collaborate with various teams to ensure compliance with internal policies and governance while optimizing site operations.

Responsibilities

• Provide day to day / routine technical HVAC & Mechanical equipment / system operations and project support for Spark.
• Cross functionally collaborate with other engineering functions as needed for routine troubleshooting (Digital Systems, Clean Utilities, etc.).
• Author and review deviations pertaining to Mechanical & HVAC systems and support impact assessments for Sparks Site / Facilities as applicable.
• Lead Root Cause Analysis and Risk Assessment Programs and address gap assessments for Spark Scientific, Technical and Manufacturing Operations.
• Support reviews of any Change Controls, Validation protocols, and CAPAs. Collaborate with operations teams on CAPA effectiveness.
• Manage on-time approval and closure of these quality records.
• Own Engineering Records, drawings, specifications, standards for Mechanical & HVAC systems.
• Site Engineering Core Team member responsible to support of activities related to the Mechanical & HVAC support functions aspects.
• System Owner for Mechanical & HVAC equipment specification and design.
• Identify changes to improve design in a cGMP environment.
• Own Small CAPEX projects, develop and implement process improvements / optimizations or continuous improvements.
• Provide Subject Matter Expert (SME) knowledge as required on process within the area of responsibility.
• Support the lifecycle Validation process, in part by being the site lead and SME for DRDQ and FCCA documentation, development and execution.
• Attend and execute equipment Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) at vendor sites and Spark site(s).
• Act as a liaison between Spark Operations, Clean Utilities, Automation Engineering and Capital project teams for large CAPEX projects, tech transfers and Site / Facility optimizations.
• Support Large Capex Projects as Mechanical & HVAC system(s) owner.
• Participate as System owner support in analysis of Site / Facility performance.
• Support cross functional teams in analysis of technically Site / Facility design concepts, methods and standards to be implemented at site.
• Provide support to Regulatory for authoring relevant sections of submissions and to Quality for deviation investigations, CAPAs and change controls.
• Manage contract and internal resources to execute site related capex projects ranging up to $10MM in accordance with site priorities and company initiatives / goals.

Requirements

• BS or MS (MS preferred) Engineering degree in a relevant field or area of specialization (Mechanical / Industrial engineering).
• 10 plus years' experience in cGMP Biotechnology, pharmaceutical or equivalent Engineering Service oriented industry.
• Development and lifecycle maintenance of Engineering Records, Standard, Specifications and Drawings.
• Experience working within a BSL-2 environment.
• Experience with Mechanical and HVAC Systems including supporting Facilities Infrastructure (HVAC Systems, Fans, Pumps, Boilers, chillers, cooling towers, hydronic systems etc.).
• Experience with Cleanroom Design a plus.
• Previous Mechanical & HVAC equipment / system commissioning, qualification, validation experience.
• Previous experience leading the DRDQ and FCCA efforts.
• Mechanical & HVAC Equipment troubleshooting, testing, startup/turnover, lifecycle maintenance experience.
• Experience with FDA, USP, ICH, EMA, ISPE.
• Demonstrated ability to lead investigations, study execution, and produce high quality technical documentation.
• Proven track record in a CAPEX program environment.

Nice-to-haves

• Experience with Cleanroom Design.
• Familiarity with regulatory submissions and quality assurance processes.

Benefits

• Competitive salary range from $121,300 to $181,900 based on experience and qualifications.