Senior Architect - Pharmaceutical facilities

SSOE, Inc. • Durham, NC

9h

About The Position

Join SSOE’s Architecture team as a Senior Architect specializing in delivering technically sophisticated architectural solutions for complex pharmaceutical facilities. Leading the architectural design for pharmaceutical manufacturing environments demands unwavering precision and specialized technical knowledge, particularly in highly regulated cleanroom settings. In this senior role, you will champion the full project lifecycle by delivering architectural solutions that align rigorously with FDA, EMA, ISPE, and cGMP requirements. Utilizing advanced BIM methodologies in Revit paired with AutoCAD for detailed drafting, you will develop and refine spatial layouts, cleanroom sizing calculations, material specifications and system selections (such as antimicrobial wall finishes, vapor-permeable ceiling panels, and specialized HVAC integration) must align to contamination control protocols. Your expertise will drive the coordination with multidisciplinary leads to integrate sustainable and resilient building systems tailored to pharmaceutical operations.
AI and Innovation
As part of our commitment to innovation, all team members will be trained on Microsoft Copilot and empowered to use it as a core tool in their everyday work.

Requirements

• Bachelor’s degree in Architecture from an accredited program, with active professional architectural registration preferred for responsible charge activities.
• Demonstrated architectural experience designing regulated pharmaceutical manufacturing and laboratory facilities.
• Demonstrated experience interpreting and applying FDA cGMP, EMA, ISPE Baseline Guide, and ISO 14644 cleanroom standards to architectural designs for cleanroom and controlled environments.
• Proficiency in AutoCAD, Revit, and BIM modeling, including experience with coordination and clash resolution with multidisciplinary models.
• Proven experience managing multiple project phases from conceptual design through construction administration, with a track record of meeting budget, schedule, and quality targets.
• Strong capability in client and contractor communication, including leading design reviews, responding to RFIs, and presenting technical information clearly across disciplines.

Nice To Haves

• Experience leveraging Microsoft Copilot or similar AI tools for design automation and coordination is a plus.
• Additional certifications or training in pharmaceutical facility design or cleanroom validations (e.g., Certified Pharmaceutical GMP Professional, ISPE certification) a strong plus.

Responsibilities

• Lead architectural design efforts for pharmaceutical facilities, managing project scope from concept through construction administration, including sterile and non-sterile cleanrooms, quality control labs, and support spaces, ensuring compliance with FDA, cGMP, EMA, and ISPE Baseline Guide standards.
• Develop architectural concepts, layouts, and detailed designs for pharmaceutical facilities that may include areas such as, API and OSD manufacturing areas, cleanrooms (ISO 5–8), Laboratories (QC, R&D), Packaging and warehousing, and support spaces (airlocks, gowning, material transfer), ensuring all meet regulated cleanroom classifications.
• Conduct space validation and cleanroom air change rate assessments, working closely with process engineers to confirm compliance with air handling and environmental control requirements for pharmaceutical production areas.
• Develop and maintain project BIM models in Revit, coordinating architectural elements with MEP, process, and structural disciplines to support clash detection, sustainability goals, and constructability reviews.
• Oversee documentation quality control and regulatory submission materials, reviewing architectural packages for adherence to cGMP documentation protocols and audit readiness, including digital recordkeeping.
• Lead risk assessments related to design changes and ensure alignment with safety and infection control policies in cleanroom zones, adhering to OSHA and NFPA guidelines applicable to pharmaceutical facilities.
• Mentor junior architects and BIM coordinators on best practices for pharmaceutical facility design, BIM execution plans, and regulatory compliance documentation, fostering skill development within the team.
• Drive integration of sustainable design practices including energy-efficient building envelope design and support for LEED or WELL certification pursuits relevant to pharmaceutical campuses.
• Maintain up-to-date knowledge of ISPE Pharma Baseline Guides, USP / guidelines, and relevant NFPA codes influencing architectural design criteria.
• Utilize AI/Copilot integration capabilities to optimize project documentation workflows, automate QA/QC checklists, and enhance multidisciplinary communication.

Benefits

• Includes comprehensive health, dental, and vision insurance, life insurance, 401K retirement savings plan (with company matching), opportunities for professional development and training (including support for relevant licensure & certifications), and generous PTO & paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees