CQV Specialist I (Contractor)

Key Responsibilities

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant to support facility, equipment, utility and computerized system validation
• Supports multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks
• Supports technical and quality investigations, CAPAs and corrections
• Develops and performs any required remediation efforts and associated CAPA plans
• Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews

  Requirements

  • A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
  • A minimum of 4 years relevant work experience is required. Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance is preferable.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices is required.
  • Strong interpersonal and written/oral communication skills are required.
  • Ability to quickly process complex information and often make critical decisions with limited information is required.
  • Proficient in applying process excellence tools and methodologies is required.
  • Ability to independently be responsible for a portfolio of ongoing projects is required.
  • Ability to pay attention to details and follow the procedures is required.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Good written and verbal communication skills are required.
  • Experience with team-based collaborations is a requirement.
  • Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
  • Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols is required.
  • Experience with TrackWise, CMMS and Maximo is required.
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required.