Senior Validation Specialist

3 days ago


Grand Rapids, Michigan, United States Compli Full time
Job Description

Senior Validation Specialist – Life Sciences Group

COMPI is a leading engineering contracting and consulting services company with a life sciences division specializing in pharma, biotech, API, Medical Device and laboratory facilities. We are seeking an experienced Senior Validation Engineer to join our team.

Key Responsibilities:

  • Support client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
  • Prepare and execute commissioning/validation lifecycle documents
  • Participate in various stages 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
  • Able to manage and execute multiple projects to meet client priorities
  • Provide a practical approach to problem-solving
  • Represent COMPI at client sites and interact confidently with clients, contractors, management, and peers

Requirements:

  • Bachelor's degree in a related life sciences or requisite industry training and experience
  • 5-10 years 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
  • 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
  • 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, PowerPoint, and Project

What We Offer:

  • On-the-job training provided by the validation team and manager
  • Industry training and certification courses, both online and in-person
  • Opportunity to work with a leading engineering contracting and consulting services company
  • Chance to develop project-specific validation plans and strategy
  • Collaborative work environment

Requirements for Employment:

  • Legally eligible to work in the United States
  • Willingness to travel regionally and/or nationally throughout the U.S.

Equal Opportunity Employer:

COMPI is an equal opportunity employer and welcomes applications from diverse candidates.



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