Sr. Validation Project Lead Medical Device

Job: Sr. Validation Project Lead - Medical Device

Location: Richmond VA or Baltimore MD

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 its 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 Youll Do:

• Support Client commissioning / validation for facility utility equipment and systems 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
• Provide project reporting (e.g budget status and schedule reports)
• 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
• Able to manage and execute multiple projects to meet clients priorities
• Provide a practical approach to problem solving
• Individuals must represent Compli at client sites and interact confidently with clients contractors management and peers
• Other duties as assigned.

What Youll Bring:

• Must have minimum 7 years CQV experience with aseptic liquid fill critical utilities (WFI Clean Steam Clean Compressed Air etc.) capital projects.
• Bachelors degree in a related life sciences or requisite industry training and 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
• Considered a Subject Matter Expert (SME) in one area 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
• 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 in technical writing
• Proficient in Microsoft Word Excel Power Point and Project

Travel: Local personnel preferred.

*This role is not open to C2C staffing.

Its more than just a job

At Compli we are about innovative and intelligent people who want to solve problems. Were 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.