Senior Validation Engineer

1 week ago


Lakewood, New Jersey, United States MRINetwork Jobs Full time
Job Title: Senior Validation Engineer

Job Summary:

We are seeking a highly skilled Senior Validation Engineer to join our team at MRINetwork Jobs. As a key member of our team, you will be responsible for ensuring the quality and integrity of our equipment and sterilization processes.

Key Responsibilities:

  • Develop and implement validation protocols and reports for equipment and sterilization processes.
  • Provide technical expertise and guidance on qualification, prequalification, and requalification activities.
  • Prepare and review technical documents, including change controls, regulatory submissions, and deviation investigations.
  • Perform validation activities in aseptic pharmaceutical environments.
  • Implement and ensure compliance with regulatory requirements and guidance.
  • Provide technical support for start-up activities, temperature mapping, and sterilization programs.
  • Lead or provide technical support for root cause investigations and continuous improvement initiatives.
  • Coordinate with cross-functional teams to improve productivity, quality, and continuous improvement of sterilization processes.
  • Participate in internal and external audits, including regulatory inspections.

Requirements:

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Microbiology, or a related field.
  • Minimum of three years of relevant experience in validation activities within an aseptic pharmaceutical environment.
  • Familiarity with current industry practices and guidelines, including FDA, ISO, EU, and ICH.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and MS Project.

What We Offer:

As a Senior Validation Engineer at MRINetwork Jobs, you will have the opportunity to work with a talented team of professionals, develop your skills and expertise, and contribute to the success of our organization.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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