Owner's Representative

Summary

The Owner's Representative serves as the independent advocate for the facility owner throughout the planning, design, procurement, construction, commissioning, qualification, and operational readiness phases of a brownfield pharmaceutical facility project. This individual represents the owner's interests exclusively and provides technical, financial, schedule, quality, and risk oversight to ensure project objectives are achieved safely, compliantly, on schedule, and within budget.

The ideal candidate possesses extensive experience leading pharmaceutical facility expansions, retrofits, conversions, sterile fill-finish facilities, cleanroom construction, utilities implementation, equipment integration, CQV activities, and cGMP readiness programs.

Project Context: Small isolator-based sterile peptide fill-finish line (~200K vials/month, all lyophilized), ~1,400 SF ISO 7/8 cleanroom, RUO initially with future cGMP readiness, located within ...