CQV Engineer

Katalyst CRO; Raritan (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in New Jersey seeks a senior CQV professional to support commissioning, qualification and validation for our cell therapy manufacturing plant, ensuring compliant operations and data integrity. You will lead CQV protocols, summary reports, CAPAs and investigations, mentor junior staff, and coordinate with QA, manufacturing and regulatory teams for audits and product release.

Candidates should have 8+ years of CQV experience in aseptic cell therapy environments, with strong

Qualifications

• Bachelor's degree in science, engineering, or equivalent
• 8+ years of relevant experience in aseptic or cell therapy manufacturing
• Experience with CQV in cGMP environments
• Knowledge of FDA/EU guidance for cell-based products
• Strong communication and cross-functional collaboration

Responsibilities

• Lead commissioning, qualification, requalification, and validation activities in the plant.
• Manage multiple CQV projects with cross-functional teams and report status.
• Own investigations, CAPAs, and remediation plans.
• Prepare CQV master/test protocols, summaries, and data packages.
• Develop risk assessments, FMEAs, and periodic qualifications.
• Train junior staff; support regulatory and internal audits.
• Ensure data integrity and adherence to cGMP/cGTP requirements.

Skills

CQV expertise

Regulatory audits

Project management

Team mentoring

Communication skills

Detail oriented

Independent worker

Education

Bachelor's Degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye AVS

Kaye Valprobe

Microsoft Office Suite

Job description

Summary

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, 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.

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.