Senior Validation Specialist
Philadelphia Metro Area, PA
BS in Engineering or related field with 10 years experience in Pharma validation
- 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 collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle.
- Continually ensures systems and facilities comply with regulatory and Quality process requirements.
- Major Responsibilities
- 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.
- GeneratesValidationProject 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
- AuthorsValidationProtocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes.
- AuthorsValidationProtocols 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