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Quality Assurance Validation Specialist

2 months ago

Austin, Texas, United States ICU Medical Full time

Position Overview
As a Validation Engineer, you will engage in essential validation tasks, which include crafting and executing protocols, and assessing qualification and validation statuses under the guidance of senior engineers and managers.

This role offers the opportunity to gain insight into complex tasks within the validation domain. You will work independently while also collaborating with team members, handling intermediate to advanced projects with minimal oversight.

Key Responsibilities

  • Lead and execute validation activities for manufacturing equipment, utilities, and facility validation to support tech-transfer initiatives.
  • Draft validation plans, protocols, and reports tailored to specific projects.
  • Conduct validation risk assessments for various projects, facilities, and products.
  • Independently gather, organize, and analyze validation data, keeping management informed of progress and challenges.
  • Tackle diverse and complex problems, utilizing data analysis to evaluate identifiable factors.
  • Work autonomously after receiving assignments.

Additional Duties

  • Employ innovative approaches to resolve intricate issues.
  • Integrate subsystems and components into comprehensive system designs.
  • Develop specifications based on customer requirements.
  • May oversee project-specific activities and train new or current employees on documentation, equipment usage, laboratory techniques, and departmental procedures.
  • Communicate effectively with various stakeholders, ensuring information is tailored to their needs to foster collaboration.
  • Address conflicts and disagreements openly, striving for collaborative resolutions and consensus.
  • Participate in special projects as needed.

Knowledge & Skills Required

  • Strong understanding of validation and regulatory standards.
  • Ability to recommend solutions to critical validation issues.
  • Capable of making significant decisions that impact project success.
  • Advanced knowledge in tech-transfer, process, and cleaning validation, with familiarity in other relevant areas.

Minimum Qualifications

  • Must be at least 18 years of age.
  • Bachelor's degree from an accredited institution is required.
  • 4-7 years of experience in validation, science/technical, or engineering, preferably in pharmaceutical validation or engineering.
  • A master's degree with 2 years of relevant experience may also be considered.

Work Environment

  • This role is primarily sedentary.
  • Operates in a professional office setting and utilizes standard office equipment.
  • Work is conducted in a clean room environment.
  • Occasional lifting of objects up to 25 pounds may be required.
  • Travel is typically less than 5% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.