C&Q Agent

Within SSOE's Advanced Technology division, we specialize in high-tech facility design, offering top-tier design and engineering services to a diverse array of clients and markets. Our team is composed of highly skilled and knowledgeable professionals who excel across various disciplines. What sets us apart is our ability to seamlessly conceptualize, plan, and detail every aspect of design. Our in-house experts collaborate closely, optimizing and enhancing our work through multi-discipline strategy sessions. By leveraging cutting-edge techniques and state-of-the-art software, we deliver industry-leading technology and innovative solutions from day one.

SSOE is looking to hire a C&Q Agent to join our team of experts in delivering cutting-edge solutions to our clients. You will play a pivotal role in shaping the future of advanced industrial, semiconductor, biotech, healthcare, and pharmaceutical facilities for the world's leading high-tech companies. This role focuses on executing commissioning and qualification activities with increased technical autonomy while supporting senior team members in complex project phases. The position emphasizes protocol execution, compliance with regulatory standards, and hands-on field verification for pharmaceutical, biotech, or advanced manufacturing facilities. This position will be a hybrid position, requiring occasional onsite work. Fully remote or travel work arrangements for this role are not available.

Support the development and implementation of Commissioning and Qualification Master Plans (CQMPs/VMPs) under senior oversight.
• Author and review C&Q documentation, including:
  
  • IQ/OQ/PQ protocols and reports
  • FAT/SAT protocols
  • Traceability Matrices
  • Commissioning Test Procedures (CTPs)
  • Deviation/Discrepancies
• Execute field testing for systems such as clean utilities (WFI, clean steam), HVAC (ISO 5-8 environments), and process equipment (autoclaves, bioreactors).
• Execute field testing for systems such as domestic water, gases, chillers, boilers, HVAC systems, cooling towers, electrical distribution, and other mechanical building systems.
• Ensure adherence to cGMP (21 CFR 210/211), GDP, and FDA/EMA guidelines during protocol execution.
• Review design documents (P&IDs, schematics) and vendor submittals for compliance with C&Q requirements.
• Coordinate with cross-functional teams (engineering, construction, vendors) to resolve technical issues.
• Conduct startup and functional testing for Building Management Systems (BMS) and Environmental Monitoring Systems (EMS).

• Bachelor's degree in chemical/mechanical engineering, Life Sciences, or related field.
• 5-7 years of hands-on C&Q experience in FDA-regulated industries (pharma, biotech, medical devices).
• Proven ability to execute protocols for utilities, HVAC, and process equipment. Demonstrated knowledge or experience with systems containing HVAC, chillers, boilers, pump hydraulics, exhaust, process chemicals, wastewater discharge, or other similar mechanical building systems.
• Proficiency in Microsoft Office
• Familiarity with ISPE GAMP5, ASTM E2500, and risk assessment methodologies.
• Working knowledge of BMS/EMS systems (e.g., Siemens, DeltaV).
• Strong technical writing abilities for protocols and reports.
• Ability to manage multiple priorities and meet project deadlines.
• Effective communication with clients and contractors.
• Exposure to sterilization systems or temperature mapping.
• Salary Range: $80,000 - $110,000/year depending on location, education, experience, and any certifications that are directly related to the position.
• Benefits include health, dental, and vision insurance, life insurance, 401K retirement savings plan (with company matching), opportunities for professional development and training, generous PTO & paid holidays.

Join us at SSOE, where your expertise will thrive in a dynamic, collaborative environment dedicated to pushing the boundaries of design and engineering excellence. If you're passionate about innovation and eager to make a significant impact, we invite you to apply and become a part of our forward-thinking team.