Sr. Validation Engineer in Irvine, CA at Apex Life Sciences

Date Posted: 9/11/2018

Job Snapshot

Job Description


Sr. Validation Engineer

Duties:

  • The Validation Sr. Engineer will primarily be responsible for developing and executing validation plans and protocols for manufacturing, cleanroom utilities and equipment across all qualification activities for complex systems and product line assemblies, ensuring that assigned projects are completed in a timely manner and in accordance with internal and external regulatory standards. 
  • A key element of this role will be to collaborate with project stakeholders to ensure integrity of the validation process and the timely resolution of issues.   This position will report to the Engineering Manager of Global Validation for the Valve Network.
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  • Skills:
  • Demonstrated ability to read manufacturing equipment drawings and equipment manuals to understand basics of new process /equipment and anticipate risk.
  • Demonstrated use of a process to develop a validation strategy for manufacturing, controlled environments, equipment and software for pharmaceutical or medical device manufacturers.  This includes the ability to estimate project timelines based on validation experience.
  • Proven engineering skills and experience to validate manufacturing equipment, controlled environments and software within a FDA regulated manufacturing environment.
  • Use of Microsoft Office Suite for creating documents and Minitab to perform statistics that will demonstrate stability and reliability.
  • Demonstrated knowledge and use of project management, problem solving and issue resolution tools/methods.
  • Hands-on experience using data logging equipment and air sampling equipment.
  • Experience directing and overseeing technicians to support validation execution of protocols and methodologies to minimize deviations during execution.
  • Experience in Autocad and converting supplier drawings to alternate templates is preferred Excellent writing skills Communication and Interpersonal skills at all levels of employees, suppliers, and consultants to support professional excellence Self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent

Education:

  • A Bachelor's degree in engineering or science is required with minimum 8 years experience, or equivalent hands-on experience developing validation strategy and executing validations.  
  • Experience must be hands-on execution of validations, including coordination of support technicians and cross-functional resources.

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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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