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Design Verification Lead Consultant
Stark Pharma Solutions Inc
- Richmond, Virginia, United States
- Richmond, Virginia, United States
Über
Design Verification Lead Consultant Location:
Huntsville, AL / Richmond, VA Duration:
Long Term Overview
Seeking an experienced Design Verification Lead to support a new pharmaceutical drug substance manufacturing facility buildout. This hands‑on role will lead design verification activities for facilities, utilities, equipment, automation systems, and processes to ensure compliance with GMP and regulatory requirements. 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.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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