Validation Engineer

4 weeks ago


Grand Rapids, United States Intellectt Inc Full time

Title: Validation Engineer

Location: Rapids, MI

Duration: 06+ months


Key Responsibilities:

  • Validation Strategy Development: Collaborate with clients to develop validation strategies tailored to their specific aseptic manufacturing processes and equipment.
  • Validation Protocol Generation: Lead the development and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for aseptic manufacturing systems.
  • Risk Assessment: Conduct risk assessments to identify and mitigate potential risks associated with aseptic manufacturing processes and equipment.
  • Documentation Management: Ensure accurate and comprehensive documentation of validation activities in accordance with regulatory requirements and company standards.
  • Technical Support: Provide technical support to clients during regulatory inspections and audits, including responding to inquiries and addressing findings related to validation activities.
  • Continuous Improvement: Stay abreast of industry trends and regulatory updates related to aseptic manufacturing validation and contribute to continuous improvement initiatives within the organization.
  • Client Relationship Management: Build and maintain strong relationships with clients, serving as a trusted advisor on validation-related matters.


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