Senior Capital Projects Engineer - Pharma GMP Cleanroom

Katalyst CRO; Waco (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks an experienced Project Manager for capital projects supporting ophthalmic drug manufacturing facilities in Waco, TX. You will lead design reviews, coordinate contractors, and manage schedules to deliver cleanrooms, utilities and filling line equipment in compliance with FDA and regional regulations.

The role requires extensive pharmaceutical project management experience, strong stakeholder coordination, and a track record of large-scale construction programs.

Qualifications

• Degree or diploma in a Science, Engineering, Production or Construction Management discipline.
• Minimum 5 years' experience in pharmaceutical industry and 10+ years in construction management.
• Technical understanding of design drawings including HVAC, clean utilities, black utilities, electrical and process equipment.
• Experience coordinating with architectural firms, CM teams and trades to maintain schedules.
• Experience on projects valued over $10 million.
• Knowledge of GMP pharmaceutical manufacturing technology and regulatory requirements.
• Experience with commissioning and validation of process and building equipment.
• Experience completing final walkdowns and turnover packages with vendors and contractors.

Responsibilities

• Leadership for new equipment or facility capital investment projects at the Client's Waco, Texas site.
• Lead stakeholders and SMEs through design reviews for facility and manufacturing equipment.
• Deliver capital plan latest best estimates (LBE) as per established finance frequency.
• Deliver periodic project status reports and gate reviews; track progress against schedules.
• Coordinate and lead shutdown-related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering turnover packages.
• Develop and adhere to engineering standards for facilities, utilities and equipment.

Skills

Engineering

Project management

Regulatory compliance

Education

Science/Engineering/Construction Management degree

Job description

Katalyst CRO seeks an experienced Project Manager for capital projects supporting ophthalmic drug manufacturing facilities in Waco, TX. You will lead design reviews, coordinate contractors, and manage schedules to deliver cleanrooms, utilities and filling line equipment in compliance with FDA and regional regulations.

The role requires extensive pharmaceutical project management experience, strong stakeholder coordination, and a track record of large-scale construction programs.