Validation Expert

6 days ago

Conshohocken, Pennsylvania, United States Gahagan & Bryant Associates Inc Full time
About the Role

Gahagan & Bryant Associates Inc is seeking a highly experienced Senior Validation Engineer to join our Life Sciences division. As a key member of our team, you will be responsible for supporting client commissioning and validation projects, preparing and executing commissioning and validation lifecycle documents, and participating in various stages of clinical or commercial production.

Key Responsibilities
  • Commissioning and Validation Support: Provide technical expertise to clients on commissioning and validation projects, including facility, utility, equipment, cleaning, and process validation.
  • Document Preparation and Execution: Prepare and execute commissioning and validation lifecycle documents, including protocols, reports, and other relevant documents.
  • Project Participation: Participate in various stages of clinical or commercial production, including green field construction, facility renovation, new product development, product launch, or product/process upgrade.
  • Reporting and Communication: Write summary reports for validation and qualification protocols, and provide regular updates to clients and internal stakeholders.
  • Project Management: Support project milestones, priorities, and deadlines, and ensure timely completion of projects.
  • Procedure Development: Write operating procedures for technical equipment and practices, and develop procedures for quality control and assurance.
  • Risk Assessment and Analysis: Perform system and process risk assessments and analyses to identify potential risks and develop mitigation strategies.
  • Protocol Execution and Coordination: Schedule and coordinate protocol execution with other departments, including manufacturing, facilities, and project management.
  • Validation Planning and Strategy: Develop project-specific validation plans and strategies to ensure compliance with regulatory requirements.
  • Project Execution and Management: Manage and execute multiple projects to meet client priorities, and provide a practical approach to problem-solving.
Requirements
  • Education: Bachelor's degree in a related life sciences or engineering field.
  • Experience: Minimum 5 years of GMP experience, with a strong background in validation and commissioning.
  • Skills: Ability to converse about scientific matters, strong technical writing skills, and proficiency in Microsoft Office applications.
  • Regulatory Knowledge: In-depth understanding and application of validation principles, concepts, practices, and standards, including current Good Manufacturing Practices and other applicable regulations.
  • Industry Expertise: Considered a Subject Matter Expert (SME) in one area of validation, with experience in sterile/aseptic facility CQV, thermal mapping, sterilization/SIP, and other relevant areas.
  • Communication and Collaboration: Ability to work independently or in collaboration with others, with excellent written and verbal communication skills.

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