Validation Engineer II (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 11/2/2018

Job Snapshot

Job Description


   

Summary:

This position is responsible for ensuring validations are addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines Provides support for process validation including new product development and legacy product manufacturing.

This position will also require Test Method Validation (TMV) Experience, especially with the development of Instrument-Based Inspections of Raw Material physical parameters.  The ideal candidate will have hands-on experience with optical microscopy and of creating automated routines for conducting inspections.

Tasks and responsibilities:

  • Provide technical expertise and guidance for the preparation and execution of validation protocols and reports.
  • Review and troubleshoot anomalies, deviations, etc.
  • Resolves and consults on applicable validation compliance and manufacturing process issues.
  • Mentor and leads projects.
  • Provide technical reviews of protocols.
  • Contribute at the validation project team level for validation activities.
  • Assist in developing and providing technical training.
  • May provide guidance to less senior staff.
  • May work with hazardous materials.
  • Carries out duties in compliance with established business policies.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Perform other duties & projects as assigned.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred educational/experience:

  • BS degree or equivalent in engineering or related field.
  • Minimum 3 years related experience.
  • Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes.
  • Knowledge of analytical and physical test methods and their respective validations.
  • Comprehensive knowledge of validation documentation.
  • Knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.
  • Able to work with a variety of people on multiple projects.
  • Demonstrate problem-solving and troubleshooting skills
  • Strong verbal and written communication skills
  • Organized and detail oriented
  • Knowledge and ability to use MS Office and other manufacturing systems
  • Ability to work in a team environment

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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 844-463-6178.




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