Validation Engineer

Responsibilities:

• Excellent employment opportunity for a Validation Engineer in the Gaithersburg, MD area.
• 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 the regulatory requirements.
• Collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle.
• Will continually ensure systems and facilities comply with regulatory and Quality process requirements.
• 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 Plan 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.
• Supports Periodic Assessments on required frequency intervals
• Performs Revalidations on required frequency interval
• Resolves technical issues encountered during study execution
• Schedules resources to approve and execute validation documents
• Participating in SOP development as needed
• Supports equipment start-up, shakedown, and cycle development
• Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle
• Implements/maintains governing cGMP procedures
• Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures
• Author and review change control documents

Experience:

• Bachelor's Degree and 1-2 years of related experience.