Validation Project Lead

Job Description

Job Description

Job : Validation Project Lead

Location : Boulder, CO

Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.

Compli LLC is a full-service regulatory compliance consulting services company with a life sciences division specializing in pharma, biotech, API, Medical devices, and laboratory facilities. We are seeking an experienced Validation professional to join our growing team

• 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.

• 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.

At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.

GBA is an Equal Employment Opportunity Employer. We promote diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.