Sr. CQV Specialist

Key Responsibilities

• Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns 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.
• Train and support the junior team members on different CQV activities.
• Present CQV work to regulatory and internal audit teams.
• Making decision on corrective action in deviation events.
• Make decisions on technical approach, methodology per applicable procedure.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 7 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.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• 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.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.