Senior Architect - Pharmaceutical & Life Sciences
Listed on 2026-07-09
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Business
Regulatory Compliance Specialist
Overview
Imagine shaping the design and building of facilities that directly impact human health. At SSOE, you will not just be executing tasks; you’ll continuously expand your expertise by confronting diverse and complex technical challenges unique to the design of highly regulated pharmaceutical, biotechnology, and life sciences systems. From current Good Manufacturing Practice (cGMP) production suites and potent compound containment facilities to advanced research and development laboratories, your work will be at the intersection of architecture, engineering, and rigorous regulatory science.
You will be supported by access to advanced training, leading design and computational tools, and a collaborative culture. We foster your ambition with clear pathways for career progression, whether your aspiration is technical leadership, project management, or becoming a revered subject matter expert in GMP facility and laboratory design. All of this unfolds within a truly integrated, multidisciplinary team environment that champions knowledge sharing, innovation, and technical excellence, backed by the stability and proven delivery of a well-established firm.
- Lead and drive the architectural design and planning process for a portfolio of complex pharmaceutical and life sciences projects, including cGMP manufacturing suites, pilot plants, process development laboratories, quality control (QC) and quality assurance (QA) laboratories, research and development (R&D) laboratories, and associated warehouse and utility support facilities.
- Provide technical leadership and day-to-day oversight to internal architectural project teams, ensuring the production of coordinated, high-quality construction documents that meet stringent client specifications, current Good Manufacturing Practice (cGMP) regulations, FDA guidance, and industry standards.
- Guide the seamless integration of architectural design by collaborating closely with all of SSOE’s engineering disciplines to ensure holistic coordination, constructability, and operational performance within a GMP environment.
- Interpret and apply the relevant codes for all project phases, including in-depth interpretation and application of the International Building Code (IBC), International Existing Building Code (IEBC), International Fire Code (IFC), International Mechanical Code (IMC), NFPA 101 Life Safety Code, NFPA 45 (Fire Protection for Laboratories Using Chemicals), NFPA 30 (Flammable and Combustible Liquids Code), NFPA 400 (Hazardous Materials Code), and the full suite of accessibility codes and standards (ADA, ABA).
- Apply knowledge of occupancy classifications (H, B, F-1), control area strategies per IBC, building height and area allowances, fire area separations, fire protection and suppression systems including gaseous and water mist systems for sensitive environments, egress strategies from classified spaces, fire-resistive construction, and accessibility requirements specific to laboratory and controlled production environments.
- Interpret building code and GMP regulatory intent in ambiguous or specialized scenarios and provide authoritative guidance to internal teams, clients, and regulatory authorities.
- Lead peer reviews, quality assurance/quality control checks, and constructability reviews, with a particular focus on GMP compliance, architectural finish detailing (seamless, cleanable, chemically resistant), cleanroom envelope integrity, and avoidance of ledges, cracks, and crevices that could harbor contamination.
- Collaborate intensively with process engineers, validation specialists, commissioning/qualification (C&Q) teams, engineering, project management, and preconstruction teams in a design-build environment, contributing to early-phase planning, basis of design documentation, user requirement specifications (URS), design qualification (DQ), value engineering, target value delivery, and accelerated schedule alignment aligned with drug development milestones.
- Develop and present design concepts, technical strategies, regulatory compliance approaches, and risk assessments to clients, including facility managers, quality assurance directors, and regulatory affairs teams; actively participate in client pursuit interviews and proposal development as part of ongoing business development efforts within the pharmaceutical and life sciences sector.
- Mentor junior architects and technical staff within internal project teams, fostering deep understanding of GMP principles, cleanroom design, laboratory planning, regulatory frameworks, and the architectural detailing required for controlled environments.
- Stay current with evolving GMP regulations, guidelines, and emerging trends such as continuous manufacturing, single-use technologies, modular cleanroom construction, and advanced therapy medicinal products (ATMPs); apply this knowledge to project delivery and firm standards.
- Conduct periodic field observations and site visits to assess existing conditions within…
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