Validation Project Lead

What You'll Do

• Function as an owner’s representative and report to the client’s management lead
• Cook up internal and external resources for the flawless execution of projects
• Able to lead and execute projects to meet client’s priorities
• Ensure that projects are delivered on time and within scope
• Absorb project scope, project schedule, and project costs using appropriate verification techniques
• Measure project performance using appropriate tools and techniques
• Support Client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
• Prepare and execute commissioning/validation lifecycle documents
• Write summary reports for validation and qualification protocols
• Schedule and coordinate protocol execution with other departments including manufacturing, facilities, and project management
• Develop project-specific validation plans and strategy

What You'll Bring

• Bachelor’s degree in related life sciences or engineering field
• 7-10 years of GMP experience
• Ability to converse about scientific matters
• To work independently or in collaboration with others
• In-depth understanding and application of validation principles, concepts, practices, and standards
• Proficient in current Good Manufacturing Practices and other applicable regulations
• Experienced with all pertinent industry best practices (e.g., ISPE)
• Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR)
• Excellent written communication skills with emphasis on technical writing
• Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, and AutoCAD Lite

Travel

Prefer local to the Denver Metropolitan Area

Compensation

$95,000-$130,000 yearly