Job Description

There is a major emphasis on cleanroom design experience . Candidates must have intricate and detailed understanding of different ISO classifications, air changes, WFI, HVAC systems, and electrical systems that factor into cleanroom design.

Our client has decent in-house expertise with construction & commissioning experience, but lacks the cleanroom design experience. Even if we present candidates who nearly exclusively have design experience, without construction or commissioning experience, an interview will be requested.

Our client is a global pharmaceutical company with over 70 locations worldwide. Our client's sterile compounding facility in Kansas is undergoing an expansion project to add a new FDA 503B outsourcing facility, and is in need of a Sr. CAPEX Project Manager to oversee and lead the full project lifecycle. This consultant will oversee design through construction, commissioning, validation, and commercial start-up, and ensure the successful delivery of a state-of-the-art 503B sterile compounding facility. The project is currently in the design phase.

This is a 12-month assignment based onsite in Kansas 5 days/week. Occasional travel to corporate HQ in Texas may be required. There is a strong likelihood of extension based on performance.

Responsibilities :

• Lead the execution of Project in compliance with FDA 503B, cGMP, and the Client's Project Realization Framework (PRF).
• Oversee detailed design, ensuring technical accuracy, regulatory alignment, and adherence to project scope.
• Manage engineering, construction, and automation contractors, including scope, schedule, budget, and deliverables.
• Drive FAT/SAT, commissioning, validation, and qualification for all process and utility systems.
• Ensure safety, quality, and regulatory compliance across all project stages.
• Deliver executive-level reports and presentations (progress updates, dashboards, financial summaries).
• Collaborate with operations, quality, supply chain, and finance teams to ensure readiness for commercial production.
• Identify and manage project risks and opportunities, applying proactive mitigation and value engineering approaches.

Qualifications :

• BS in Engineering, Pharmacy, Life Sciences, or a related discipline; PMP certification preferred
• Minimum 8 years of experience in pharmaceutical or biotech project management, ideally in aseptic or sterile compounding facility projects
• Proven track record in CAPEX project execution, including design-build delivery, budget control, scheduling, and risk management.
• Deep understanding of FDA 503B, cGMP, USP <797>/<800> , ISO cleanrooms, HVAC systems, WFI, isolators, and automation technologies
• Familiarity with value engineering and ROI-driven project delivery
• Strong leadership and stakeholder management across multidisciplinary teams, excellent communication skills, and strong critical thinking and problem-solving skills.

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