Job: Validation Project Leader

Location: Lenexa, KS

Compli, LLC, a George Butler Associates’ affiliate, was founded in 2001 to provide commissioning, validation and regulatory support services to the life sciences industry.

We serve pharmaceutical and life science companies across North America. With regard to regulations and compliance, it’s 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.

What You'll Do:

• Lead project teams related to the commissioning and qualification of equipment, facilities, utilities, process and cleaning validation
• Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects as needed
• Develop project specific validation plans and strategy documents
• Author and implement associated validation and quality system policies and procedures
• Prepare and execute commissioning / validation documents as needed
• Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade
• Drive and determine 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
• Able to manage and execute multiple projects to meet client’s priorities
• Provide a practical approach to problem solving
• Other duties as assigned

What You'll Bring:

• Bachelor’s degree in a related life sciences or engineering field
• 10 plus years of GMP experience
• Ability to converse about scientific matters
• Ability to manage a project team
• In depth understanding and application of validation principles, concepts, practices and standards
• Considered a Subject Matter Expert (SME) in multiple areas of validation
• 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
• Preferred prior experience in performing CQV services on the following systems / equipment:
  • Utilities including HVAC systems and Purified Water / Water for Injection Systems
  • Lyophilizers / Freeze Dryers
  • Spray Dryers
  • Aseptic Fill Lines and associated equipment
  • Blending Equipment
• Demonstrated expertise in multiple aspects 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 in technical writing
• Proficient in Microsoft Word, Excel, Power Point and Project
• Must be willing to travel regionally and / or nationally throughout the U.S.

Travel:

· Local personnel preferred.

It’s more than just a job…

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.

At Compli, we are an Equal Employment Opportunity Employer promoting 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.