CQV Engineer (Cell Therapy Manufacturing)
Not Disclosed•ContractorOn-site
location_on18, Tillman Street, Raritan, Somerset County, New Jersey, 08869, United States
About the Opportunity
Intellectt Inc. is connecting top-tier talent with a prestigious client for a contract role as a Senior CQV Engineer in Cell Therapy Manufacturing. This position is based in Raritan, NJ, and focuses on supporting a cGMP Clinical and Commercial plant dedicated to personalized cell therapy production.
The role exists to ensure safe, compliant manufacturing operations that enable the robust production, testing, and release of life-saving products to patients. You will serve as a key representative for CQV work during regulatory and internal audits, driving effective communication and collaboration across cross-functional groups to maintain a strong, compliant CQV program.
Day in the Life
In this role, you will manage multiple complex CQV projects, handling day-to-day activities that include protocol management, vendor coordination, and the execution of commissioning, qualification, requalification, and validation activities. You will own technical and quality investigations, including CAPAs and corrections, while developing remediation efforts to address gaps in processes or systems.
A significant portion of your time will be dedicated to authoring, executing, and reviewing master CQV protocols, summary reports, change controls, and SOPs with a strict focus on data integrity. You will also participate in risk assessments, FMEAs, and periodic qualifications, while training and supporting junior team members on various CQV activities.
Application Instructions
To express interest in this opportunity, please share your updated resume with Jayadev at jayadev.g@intellectt.com.
Equal Opportunity
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Work location
Work model: On-site
18, Tillman Street, Raritan, Somerset County, New Jersey, 08869, United States
Raritan, New Jersey
Key Responsibilities
- check_circleParticipate in authoring Risk Assessments, FMEAs, Project Plans, and Annual Product Reviews
- check_circleTrain and support junior team members on CQV activities
- check_circlePresent CQV work to regulatory and internal audit teams
- check_circleExecute commissioning, qualification, requalification, validation, and maintenance activities within the plant
- check_circleManage complex CQV projects and coordinate with cross-functional teams, vendors, and contractors
- check_circleAuthor, execute, and report on master and completed CQV protocols and summary reports
- check_circleOwn technical and quality investigations, CAPAs, corrections, and remediation efforts
- check_circleCreate, revise, and review change controls, SOPs, and other documentation
Requirements
- verifiedBachelor's Degree in Science, Engineering or equivalent technical discipline
- verified8+ years relevant work experience
- verifiedExperience working in an aseptic manufacturing facility, preferably cell therapy
- verifiedKnowledge of cGMP regulations and FDA/EU guidance
- verifiedKnowledge of Good Tissue Practices (cGTP)
- verifiedExperience with ICH and/or 21 CFR parts 210, 211, 1271
- verifiedExperience authoring and executing documentation including Batch Records, SOPs, Work Instructions, CQV protocols
- verifiedProficiency in Microsoft suite
- verifiedProficiency in ERP systems: Maximo, Siemens EMS, Comet, Kneat
- verifiedProficiency in Testing systems: Kaye AVS, Kaye Valprobe
Nice to Have
Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Experience with 21 CFR parts 600, 601, and 610.
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Skills, education and keywords
Skills: Microsoft Suite, Maximo, Siemens Ems, Comet, Kneat, Kaye Avs, Kaye Valprobe, CQV, CGM P, Good Tissue Practices.
Education: A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required..
Frequently asked questions about CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc
What does a CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc do?expand_more
Day-to-day, the CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc will participate in authoring risk assessments, fmeas, project plans, and annual product reviews; train and support junior team members on cqv activities; present cqv work to regulatory and internal audit teams; and execute commissioning, qualification, requalification, validation, and maintenance activities within the plant.
What are the requirements for this CQV Engineer (Cell Therapy Manufacturing) role?expand_more
To qualify for the CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc position, applicants should have: Bachelor's Degree in Science, Engineering or equivalent technical discipline; 8+ years relevant work experience; Experience working in an aseptic manufacturing facility, preferably cell therapy; Knowledge of cGMP regulations and FDA/EU guidance; Knowledge of Good Tissue Practices (cGTP); and Experience with ICH and/or 21 CFR parts 210, 211, 1271.
Where is the CQV Engineer (Cell Therapy Manufacturing) role at Intellectt Inc located?expand_more
CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc is based in 18, Tillman Street, Raritan, Somerset County, New Jersey, 08869, United States. This is a on-site role.
Is this CQV Engineer (Cell Therapy Manufacturing) job remote, hybrid, or on-site?expand_more
Intellectt Inc has listed this CQV Engineer (Cell Therapy Manufacturing) role as on-site.
How much experience is required for this CQV Engineer (Cell Therapy Manufacturing) role?expand_more
CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc typically requires 8+ years of relevant experience at the senior level.
What skills do you need for the CQV Engineer (Cell Therapy Manufacturing) role at Intellectt Inc?expand_more
Key skills for CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc include Microsoft Suite; Maximo; Siemens Ems; Comet; Kneat; Kaye Avs; Kaye Valprobe; and CQV.
What education is required for CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc?expand_more
Educational requirements for this role: A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required..
What category does the CQV Engineer (Cell Therapy Manufacturing) role belong to?expand_more
CQV Engineer (Cell Therapy Manufacturing) at Intellectt Inc is part of the engineering job category on Recrutus.