Design Verification Lead Consultant

Key Responsibilities

• Lead Design Verification (DV) activities across facility and process systems.
• Review P&IDs line-by-line and verify design intent.
• Develop and review URS, DV plans, protocols, reports, traceability matrices, and risk assessments.
• Support facility design from pre-concept through commissioning and startup.
• Review vendor FDS, DDS, and engineering documentation.
• Manage change controls, FAT/SAT alignment, and commissioning support.
• Evaluate material flow, personnel flow, and warehouse operations.
• Collaborate with Engineering, Quality, Validation, Manufacturing, and vendors.

Requirements

• Strong pharmaceutical CAPEX and facility buildout experience.
• Expertise in Design Verification, P&IDs, URS development, and GMP compliance.
• Experience with FDA, EMA, ICH Q8-Q11, and ISPE guidelines.
• Proven background supporting greenfield or site expansion projects.
• Experience with risk assessments, change control, commissioning, and qualification activities.