Roles & 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 .
" 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.
" Support presenting CQV work to regulatory and internal audit teams.
" Other responsibilities as assigned.
" Making decision on corrective action in deviation events
" Make decisions on technical approach, methodology per applicable procedure
" Manager approval required for resource assignment, timeline shift, strategic shift and finance related events
Requirements:
"A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
"A minimum of 8+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance
" Ability to use following or similar systems for business needs,Microsoft suite
ERP systems: Maximo, Siemens EMS, Comet, Kneat
Testing system: Kaye AVS, Kaye Valprobe
" 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.