Design Verification Lead

Blackfield Associates are currently partnered with a global pharmaceutical manufacturer to support their search for an Design Verification Lead to join their project based in Texas on an initial 12-month contract.

Key Responsibilities

• Serve as the technical lead responsible for design verification of assigned process, utility, equipment, or facility systems throughout the project design phase.
• Act as the designated System Owner, ensuring engineering designs meet operational requirements, GMP expectations, applicable codes, and company engineering standards.
• Lead the technical review and approval of engineering deliverables, including drawings, specifications, calculations, datasheets, and design packages.
• Verify that designs developed by Architecture & Engineering partners align with project requirements, user needs, and business objectives.
• Own equipment, facility, and system specifications, ensuring technical accuracy and compliance throughout the design lifecycle.
• Coordinate design activities across engineering disciplines, vendors, design firms, and subject matter experts to ensure a fully integrated design solution.
• Drive design reviews, risk assessments, constructability reviews, and technical decision-making processes.
• Identify design gaps, risks, and compliance issues, ensuring timely resolution and alignment with project objectives.
• Support procurement activities by providing technical input on equipment selection, specifications, and vendor evaluations.
• Provide technical support during construction, commissioning, qualification, and start-up to ensure design intent is successfully executed.
• Ensure assigned project areas remain aligned with scope, budget, schedule, and regulatory requirements.

Experience Required

• Bachelor's degree in Engineering or a related technical discipline.
• Significant experience in pharmaceutical, biotechnology, or GMP-regulated facility design and capital project execution.
• Proven experience acting as a Design Verification Lead, System Owner, Project Engineer, or similar technical leadership role on large capital projects.
• Strong experience managing and reviewing work completed by Architecture & Engineering firms and multidisciplinary design teams.
• Comprehensive understanding of GMP facility design, engineering standards, and applicable industry codes.
• Experience reviewing and approving engineering deliverables throughout the design lifecycle.
• Strong knowledge of process equipment, facilities, utilities, and manufacturing systems within pharmaceutical environments.
• Experience supporting projects through design, procurement, construction, commissioning, and qualification phases.
• Excellent stakeholder management, communication, and technical leadership skills.
• Experience supporting small molecule API and/or biologics manufacturing projects is highly desirable.
• Experience on large-scale pharmaceutical capital projects valued at $500M+ is preferred.