Validation Engineer in Grand Island, NE at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


Description:

Validation Engineer

  • Generate, execute and report on protocols for the qualification of facilities/utilities/equipment and validation of manufacturing processes.
  • Assist in the development of user requirements for new equipment acquisitions.
  • Conduct risk assessments for equipment and processes.
  • Develop validation strategies based on regulatory requirements, scientific rationale, industry practice and assessed risk.
  • Perform P&ID and I/O verifications.
  • Participate in FAT, SAT, commissioning and startup of new equipment.
  • Provide project updates to supervisor/manager. Escalate issues and provide recommendations for resolution.
  • Assess the revalidation requirements for any equipment modifications or process changes.
  • Provide input to the Facilities Department on preventive maintenance and calibration requirements, including setting appropriate calibration tolerances and frequency of calibration.
  • Work with the Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions

    Requirements

  • Bachelor Degree in a field of science. Engineering degree is preferred.
  • 3 years of experience in the cGMP regulated industry. In-vitro diagnostic experience preferred.
  • Demonstrated experience in facility/utility/equipment qualification and process validation.
  • Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies.
  • Good understanding of ISO 13485 requirements relating to product realization and process validation.
  • Good analytical skills and ability to communicate effectively with all levels.
  • Proficient in Microsoft Word and Excel.
  • Good understanding of statistical techniques is a plus.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.