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Validation Engineer II
Ref No.: 18-07256
Location: Irvine, California
Position Type:Engg
Start Date / End Date: 06/04/2018 to 12/21/2018
Job Title: Validation Engineer II
Duration: 6 months
Location: Irvine, CA

Job Description:
  • Support validation of new and existing equipment and processes for production line usage.
  • The Validation Engineer will be responsible for creating and executing validation procedures to support company goals.
  • These validation activities will include development and revision of validation protocols and procedures, develop test plan traceability matrix, qualification and re-qualification of process equipment (IQ/OQ/PQ), and prepare reports.
Validation Activities:
  • Ensure that assigned validation activities are performed timely and in line with the current Client requirements and cGMP, handling any deviations associated with these activities.
  • Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalification)
  • Perform process qualification for new equipment and new technologies.
  • Author validation protocols and engineering studies.
  • Contribute to provide experimental data obtained during the validation activities.
  • Perform or oversee risk assessments for Validation.
  • Participate in the improvement and remediation of products.
  • Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
  • Meet established validation and revalidation milestones according to approved validation plans that do not adversely impact production schedule nor audit readiness.
  • Technical reports executed on time and with the right expectations.
  • Technical/scientific responsibility as member of the site Subject Matter Experts (SME) team.
  • Training curriculum up-to-date. All contractors (if assigned) trained according to the training curriculum.
  • 2+ years experience with manufacturing engineering or validation experience.
  • Understanding of manufacturing processes and related process equipment.
  • Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Proficient in writing and reviewing protocols and technical reports.
  • Experience working in the medical device industry preferred.
  • Experience working with a sterile packaging environment a plus.
  • Bachelor's degree in Engineering or equivalent years of relevant engineering-level experience
Anant Dwivedi | Lead Recruitment
Sunrise Systems Inc, 
105 Fieldcrest Ave Suite# 504, Edison, NJ - 08837 USA
Desk: (732)-272-0289
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