Pharma Capital Projects Lead — Cleanrooms & GMP

Katalyst Healthcares & Life Sciences; Waco (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Project Manager to oversee pharmaceutical capital projects at the Waco, Texas site. You will lead cross-functional teams through design, procurement, and commissioning of cleanrooms, utilities, and filling line equipment in line with FDA and regulatory requirements.

You will manage budgets, schedules, and stakeholder communications for projects typically valued over $10 million, ensuring GMP compliance and safe execution.

Qualifications

• Minimum 5 years' experience in pharmaceutical industry and 10+ years in construction management.
• Technical understanding of design drawings including HVAC, clean utilities, electrical and process equipment.
• Ability to work with architectural firms and CM teams in fast-paced projects.
• Experience on projects valued over $10 Million.
• Knowledge of GMP pharmaceutical manufacturing technology and aseptic manufacturing.
• Strong presentation and reporting skills.
• Experience in safety metrics and participating in HAZOPs.

Responsibilities

• Lead new capital investment projects at the Waco site, including funding definition, preliminary engineering and scheduling.
• Direct stakeholders and SMEs through facility and manufacturing equipment design reviews.
• Deliver capital plan latest best estimates (LBE) per finance schedules.
• Provide periodic project status reports and gate reviews to stakeholders.
• Control change during project execution and manage procurement activities.
• Coordinate shutdown-related activities with all stakeholders.
• Lead final walkdowns and turnover packages with vendors/contractors.
• Develop and maintain detailed project schedules and cash flow tracking.

Skills

Project management

Stakeholder management

Scheduling

Budgeting

Communication

Regulatory knowledge

Education

Degree in Science/Engineering or Construction Management

Tools

Primavera P6

MS Project

AutoCAD

Job description

Creative Solutions Services, LLC is seeking an experienced Project Manager to oversee pharmaceutical capital projects at the Waco, Texas site. You will lead cross-functional teams through design, procurement, and commissioning of cleanrooms, utilities, and filling line equipment in line with FDA and regulatory requirements.

You will manage budgets, schedules, and stakeholder communications for projects typically valued over $10 million, ensuring GMP compliance and safe execution.