Consultant Validation Engineer

at  Raland Compliance Partners

Position Overview: We are seeking a motivated and experienced Consultant Validation Engineer with a background in aseptic manufacturing to join our team. The Consultant Validation Engineer will play a crucial role in providing technical expertise and guidance to our clients in the validation of aseptic manufacturing processes and equipment. The ideal candidate will have 5+ years of relevant experience and a strong understanding of regulatory requirements and industry best practices.

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.