Validation Engineering Manager

2 days ago


San Jose, California, United States Ventura Solutions Inc. Full time
Validation Engineering Manager

We are seeking an experienced Validation Engineering Manager to lead our process validation efforts. The ideal candidate will have a strong understanding of medical device regulations and a proven track record of successfully managing validation projects.

About the Role:
  • This position requires exceptional leadership and communication skills, as well as the ability to work effectively in a fast-paced environment.
Responsibilities:
  • Develop and execute comprehensive validation plans that ensure compliance with regulatory requirements.
  • Lead cross-functional teams to complete validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Collaborate with subject matter experts to identify and address validation gaps and opportunities for improvement.
  • Provide technical guidance and support to junior validation engineers and other team members.
  • Maintain accurate records and reports to demonstrate compliance with regulatory requirements.
Requirements:
  • Bachelor's degree in Engineering or a related field.
  • Minimum 5 years of experience in process validation, with a focus on medical devices.
  • Proven leadership and management experience, with a strong track record of successful project delivery.
  • Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.
  • Strong knowledge of medical device regulations, including ISO 13485 and FDA guidelines.
Estimated Salary:

$150,000 - $180,000 per year.

Ventura Solutions Inc. offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced validation engineer looking for a new challenge, we encourage you to apply for this exciting opportunity.



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