Senior Architect - Pharmaceutical facilities

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. 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. 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.

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