Validation Specialist

2 weeks ago


Philadelphia, Pennsylvania, United States DPS Group LLC Full time
Overview
DPS Group LLC is seeking a skilled Validation Specialist to enhance our team in providing exceptional support to our innovative BioPharma clients.

Key Responsibilities
  • Commissioning, Qualification, and Validation of Equipment.
  • Conducting Temperature Mapping.
  • Assisting in Equipment Validation for projects such as autoclaves and bioreactors in a Lab/cGMP environment.
  • Understanding user, functional, installation, operation, and performance requirements for assigned tasks.
  • Reviewing documentation (P&IDs, RDs, URSs, SOPs, Specifications) to develop commissioning and validation documents.
  • Developing validation protocols, including drafting and managing review cycles.
  • Supporting the creation of Validation Master Plans.
  • Executing validation protocols using tools like Kaye Validator for various systems.
  • Assisting in the development of Equipment Validation Reports and Validation Summary Reports.
  • Preparing and processing validation documentation in an electronic document management system.
  • Supporting the resolution of Equipment Validation deviations and related documentation.
  • Coordinating activities among Client teams (validation, engineering, manufacturing, QC, etc.).
  • Aiding in the resolution of engineering and validation issues during equipment validation.
  • Participating in meetings to support equipment installation and operation.
  • Providing quality oversight for validation documents as necessary.
  • Assisting in the development of Standard Operating Procedures (SOPs).
  • Performing additional tasks as required to support the project.
Required Skills and Qualifications
  • Bachelor's degree in Chemical Engineering or a related field.
  • 2-7 years of experience in CQV validation, including temperature mapping.
  • Experience in Equipment Validation/CQV within a cGMP and FDA regulated environment is preferred.
  • Familiarity with CQV activities for equipment in a cell therapy setting is advantageous.
  • Strong understanding of equipment and automated systems is desired.
  • Previous experience in a cGMP and FDA regulated environment is essential.
  • Ability to provide legal US work authorization documents is required.
Additional Information
To succeed in this role, candidates must demonstrate the ability to perform essential duties effectively. The following attributes are essential:
  • Continuous Learning - Committed to self-assessment and professional development.
  • Team Collaboration - Fosters a positive team environment and values teamwork.
  • Customer Focus - Exhibits courtesy and responsiveness to client needs.
  • Organizational Skills - Efficiently prioritizes and plans work activities.
  • Technological Proficiency - Adapts to new technologies and keeps skills current.
About DPS Group LLC
DPS Group LLC is a global firm specializing in Engineering, Procurement, Construction Management, and Validation services across the Life Sciences and Advanced Technology sectors. We are dedicated to delivering successful projects with a client-centric approach, ensuring excellence in every aspect of our work.

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