Lead Validation Engineer in Life Sciences

2 weeks ago


Conshohocken, Pennsylvania, United States Compli Full time
Job Overview

Senior Validation Engineer (Life Sciences)

Compli is a comprehensive engineering contracting and consulting firm with a dedicated life sciences division focusing on pharmaceuticals, biotechnology, active pharmaceutical ingredients, medical devices, and laboratory facilities. We are in search of a seasoned Senior Validation Engineer to enhance our expanding team. Compli stands out through its cohesive methodology in engineering, construction, commissioning, and validation.

Key Responsibilities:

  • Assist clients with commissioning and validation for facilities, utilities, equipment, cleaning, and process validation initiatives.
  • Develop and implement commissioning and validation lifecycle documentation.
  • Engage in various phases of clinical or commercial production, including new construction, facility upgrades, product development, launches, or enhancements.
  • Compose summary reports for validation and qualification protocols.
  • Support project timelines, objectives, and deliverables.
  • Create operational procedures for technical equipment and standard practices.
  • Conduct system and process risk assessments and evaluations.
  • Coordinate protocol execution with departments such as manufacturing, facilities, and project management.
  • Formulate project-specific validation strategies and plans.
  • Manage and execute multiple projects to align with client priorities.
  • Provide practical solutions to challenges encountered.

Qualifications:

  • Bachelor's degree in a relevant life sciences or engineering discipline.
  • 8 to 10+ years of experience in Good Manufacturing Practices (GMP).
  • Ability to discuss scientific topics effectively.
  • Capability to work autonomously or collaboratively.
  • Thorough understanding and application of validation principles, practices, and standards.
  • Recognized as a Subject Matter Expert (SME) in a specific area of validation.
  • Proficient in current GMP and other relevant regulations.
  • Experience with sterile and aseptic filling processes.
  • Familiarity with industry best practices, including the development and execution of system lifecycle deliverables.
  • Demonstrated expertise in system qualification and regulatory compliance.
  • Exceptional written communication skills, particularly in technical writing.
  • Proficient in Microsoft Office Suite including Word, Excel, PowerPoint, and Project.
  • Willingness to travel regionally and/or nationally.


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