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Senior Validation Engineer

2 months ago

Kansas City, Missouri, United States Compli Full time
Job Description

**About Compli**

Compli is a leading engineering contracting and consulting services company with a life sciences division specializing in pharmaceuticals, biotechnology, API, medical devices, and laboratory facilities.

**Job Summary**

We are seeking an experienced Senior Validation Engineer to join our team. As a Senior Validation Engineer, you will be responsible for supporting client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects.

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 Compli 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
  • 3 – 5 years GMP experience
  • Aseptic process experience preferred
  • Critical utility experience preferred
  • 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 in technical writing
  • Proficient in Microsoft Word, Excel, PowerPoint, and Projects
  • Salary range is 85-175K, depending on experience level

What We Offer:

On-the-job training will be provided by the validation team and manager, and through industry training and certification courses, both online and in person.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer M/F/D/V