Senior Mechanical Engineer

Overview

Join SSOE where innovation meets impact. We are at the forefront of designing and delivering cutting-edge solutions for the world's most demanding state-of-the-art pharmaceutical, life science, biotech, healthcare, semiconductor, and advanced industrial facilities. As a Senior Mechanical Engineer, you will be instrumental in shaping the future of these critical facilities, working alongside a team of experts to ensure that our projects exceed industry standards and client expectations. We foster a collaborative, growth-oriented environment where your expertise is valued, and your contributions drive tangible results.

We are seeking a lead engineer to tackle challenging projects involving HVAC, cleanroom, and process utility design, ensuring strict adherence to cGMP and FDA standards. Your expertise will be vital in delivering high-quality solutions for API, Pharmaceutical, Biological, and Medical Device production within our growing Pharmaceutical and Life Sciences portfolio. If you excel in technical leadership, enjoy navigating elaborate regulatory landscapes,  and contributing to our strategic growth initiatives through client engagement and project shaping, we want to hear from you.

Responsibilities

• Lead the design and engineering of complex mechanical systems, including HVAC, cleanroom systems (ISO classifications), process utilities (WFI, USP Purified Water, Clean Steam), process cooling, and critical exhaust systems for pharmaceutical and biotech facilities.
• Develop detailed design calculations, equipment specifications, and construction documents that adhere to industry standards (ASHRAE, ASME, ISPE, cGMP, etc.) and regulatory requirements (FDA, EMA).
• Design and specify high purity piping systems, including sanitary and orbital welding requirements, and ensure adherence to relevant codes and standards.
• Develop designs to control temperature, pressure and humidity levels in cGMP spaces ranging from Clean-not-Classified (CNC) down to ISO-5, including directional air flow for containment.  
• Collaborate with cleanroom vendors to integrate their systems and rooms seamlessly into the overall building design, ensuring optimal performance and compliance.
• Perform detailed hydraulic and thermal analysis using software tools like PIPE-FLO, AFT Fathom, or similar, to optimize system performance and efficiency.
• Design and implement Building Management Systems (BMS) and control strategies for complex mechanical systems, ensuring precise environmental control and energy efficiency.
• Support the development and execution of commissioning and qualification protocols (IQ/OQ) for critical mechanical systems.
• Serve as a technical lead, providing guidance and direction to project teams and ensuring technical accuracy and quality of deliverables.
• Communicate effectively with clients, contractors, and other stakeholders, providing clear and concise technical information.
• Conduct thorough design reviews and quality control checks to ensure compliance with project specifications and industry standards.
• Stay abreast of the latest technologies, industry trends, and regulatory requirements related to pharmaceutical and advanced industrial mechanical systems.
• Mentor and train junior engineers, provide technical guidance and foster their professional development.
• Coordinate and collaborate with multidisciplinary teams, including electrical, structural, process/chemical, and architectural engineers, to ensure seamless integration of mechanical systems.
• Conduct thorough field verifications and site walks to assess existing conditions and identify potential design challenges.

Qualifications

• Bachelor’s Degree in Mechanical Engineering from an accredited institution.
• Active Professional Engineer (PE) license in the state of practice or the ability to obtain reciprocity within 12 months of employment.
• Demonstrated experience in the design and engineering of mechanical systems for pharmaceutical, biotech, life science, or advanced industrial facilities.
• Experience with HVAC, cleanroom systems, process utilities, and other critical mechanical infrastructure.
• Experience with design software, including Revit.  Plant 3D experience is a plus.  
• Demonstrated experience in designing and implementing control systems for temperature, pressure, and humidity in cGMP spaces, encompassing a wide range of cleanroom classifications (CNC to ISO-5).
• Proven ability to work effectively with cleanroom vendors, integrating their specialized systems into comprehensive building designs.
• Experience with hydraulic modeling software (PIPE-FLO, AFT Fathom) and thermal analysis software are highly desirable.
• In-depth knowledge of industry standards and regulatory requirements (ASHRAE