Validation Project Lead

About the role

Compli, LLC is seeking an experienced Validation Project Lead to join their growing team. The Validation Project Lead will function as an owner's representative and report to the client's management lead. They will coordinate internal and external resources for the flawless execution of projects, lead and execute projects to meet client priorities, ensure projects are delivered on time and within scope, assist in defining project scope and objectives, develop a detailed project plan to monitor and track progress, manage changes to the project scope, schedule, and costs, measure project performance, prepare and execute commissioning/validation lifecycle documents, support client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects, write summary reports for validation and qualification protocols, support project milestones, priorities, and deadlines, write operating procedures for technical equipment and practices and procedures, perform system and process risk assessments and analyses, schedule and coordinate protocol execution with other departments including manufacturing, facilities, and project management, develop project-specific validation plans and strategy, and perform other duties as assigned.

Responsibilities

• Function as an owner's representative and report to the client's management lead
• Cover all aspects of project coordination and execution
• Able to lead and execute projects to meet client priorities
• Ensure projects are delivered on time and within scope
• Assist in the definition of project scope and objectives
• Develop a detailed project plan to monitor and track progress
• Manage changes to the project scope, project schedule, and project costs
• 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
• Support project milestones, priorities, and deadlines
• Write operating procedures for technical equipment and practices and procedures
• Perform system and process risk assessments and analyses
• Schedule and coordinate protocol execution with other departments including manufacturing, facilities, and project management
• Develop project-specific validation plans and strategy
• Other duties as assigned

Requirements

• Bachelor’s degree in a related life sciences or engineering field
• 7-10 years of GMP experience
• Ability to converse about scientific matters
• Ability 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) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)
• 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

Qualifications

• Experience in project management and coordination
• Strong problem-solving and analytical skills
• Knowledge of regulatory compliance and industry standards
• Ability to work independently and collaboratively
• Strong attention to detail and organizational skills

Skills

• Project Management
• Regulatory Compliance
• Technical Writing
• MS Office Suite
• AutoCAD Lite

Benefits

Competitive pay commensurate with experience, work/life balance, working with a small, close-knit team where you are valued as an individual, and a learning environment and continuous advancement opportunities.

Pay

$95,000 - $130,000 yearly

Schedule

Prefer local to the Denver Metropolitan Area