Job PostingThe Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles, and regulatory requirements. The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle. The Validation Engineer will continually ensure systems and facilities comply with regulatory and Quality process requirements.The Validation Engineer participates in system design and commissioning project phases.
Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification. Generates Validation Project Plans for complex projects and systems Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments, and Automation Risk Assessments Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping, and method processes. Authors Validation Protocols and Reports for Controlled Temperature Units.