What are the responsibilities and job description for the Commissioning Qualification Validation (CQV) Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
- Manages multiple and complex CQV projects, 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.
- Bachelor's in science, Engineering or equivalent technical experience.
- CQV and engineering experience required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- 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.
- Ability to identify/remediate gaps in processes or systems.
- 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.
- Experience with TrackWise, CMMS and Maximo
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
- Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
- Demonstrated ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
