Job: Validation Project Lead

Location: Boulder, CO

What You'll Do:

Function as an owner's representative and report to the client's management lead
Coordinate 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.
Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
Develop a detailed project plan to monitor and track progress
Manage changes to the 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
Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
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.

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
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) and internal requirements employing regulatory guidance and industry standards
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

*This role is not open to C2C staffing.

Perks of the Job:
• Competitive Pay commensurate with experience
• Work / Life Balance
• Working with a small, close-knit team where you are valued as an individual
• A learning environment and continuous advancement opportunities

Join Our Team

Apply today and build your future with GBA.

Gahagan & Bryant Associates Inc.

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Validation Project Lead