Primary Responsibilities
This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to support timely completion of the CQV activities [i.e, Controlled Temperature Units Qualification- (Refrigerator, Freezer, Incubator, CO2 incubator), Cell Therapy Process Equipment Qualification- (CliniMACS Prodigy, NC200 Cell Counter), Cell Therapy Testing Equipment Qualification-FACSlyric, qPCR, Vi-Cell XR), Warehouse Qualification, Equipment Relocation, Equipment decommissioning, EMS System Qualification, Manufacturing and Testing Cell therapy Equipment/Instrument software upgrade related qualification, Clean room Facility Qualification/EMPQ]

• 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 CQV correction activities related to technical and quality investigations, CAPAs and corrections.
• Authors 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.
• Support in the revision and review of CQV related SOPs, and other technical documentation as required.
• Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Maintenance

Qualifications
CQV Cell Therapy 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.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• 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 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).

Education & Certifications

• Bachelor's in Science, Engineering or equivalent technical experience

Job Type: Contract

Pay: $48.00 per hour

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Experience:

• CQV Cell Therapy: 7 years (Required)
• cGMP regulations and FDA/EU guidance: 7 years (Required)
• CAR-T manufacturing or cell processing: 7 years (Required)
• ICH and/or 21 CFR parts 210, 211, 1271: 7 years (Required)
• Batch Records, SOPs, Work Instructions, CQV protocols: 7 years (Required)
• TrackWise, CMMS and Maximo: 7 years (Required)
• Microsoft Office applications: 7 years (Required)

Work Location: In person