Validation Engineer
4 weeks ago
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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