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Scientific. Clinical. Software Engineering

Senior Validation Specialist

Philadelphia Metro Area, PA

Job Type: Scientific Job Number: JN -022020-26463 Region: Philadelphia Metro Area

Job Description

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
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