Cell Therapy CQV Engineer: Validation & Compliance
Creative Solutions Services, LLC
Creative Solutions Services, LLC in Raritan, New Jersey is seeking a qualified candidate for a role focused on Commissioning, Qualification, and Validation (CQV) in the cGMP clinical and commercial cell therapy manufacturing plant. The individual will manage day-to-day activities related to protocol management and issues resolution, ensuring safe and compliant operations. The ideal candidate will have at least 8 years of experience and must be proficient with cGMP regulations, possess strong communication skills, and effectively manage complex projects. #J-18808-Ljbffr Creative Solutions Services, LLC
- ...Description Job Description Validation & Engineering Group, Inc. (V&EG) a... ...following areas: Laboratory, Compliance, Computer, Engineering, Project... ...following position: ~ CQV Engineer – Biotech... ...biotechnology, sterile manufacturing, cell therapy, or gene therapy facilities...Suggested
- Initial Therapeutics, Inc. is looking for a Validation Specialist to execute site validation activities and ensure compliance with regulations. You will oversee equipment qualifications, manage manufacturing controls, and support process validation in a dynamic biopharma...Suggested
$120k
...New Jersey, we are developing advanced cell therapies across a diverse array of technology... ...Company Legend Biotech USA, Inc Job Title Validation Specialist Job Duties Execute site... ...assessments, rationales, and approval for engineering and process changes to meet regulatory...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...Description Job Description We are seeking a Senior Validation Engineer with solid hands-on validation experience and a collaborative... ...In addition to many of the equipment seen at traditional cell & gene therapy facilities, this position will focus on the qualification...SuggestedContract workFor contractorsFlexible hours
- Piper Companies is seeking an experienced CQV Validation Engineer in Raritan, NJ, to assist with the IQ/OQ/PQ of new instruments/equipment.... ...conducting testing, and providing technical support to ensure compliance with regulations. The ideal candidate should have a...Suggested
- ...Commissioning, Qualification and Validation support to the cGMP... ...and Commercial Cell Therapy Manufacturing plant.... ...role will require CQV experience, represent... ...s Degree in Science, Engineering or equivalent technical... ..., or manufacturing compliance. Ability to use following...Work experience placementShift work
- Pinnaql is seeking an experienced CQV Engineer to support biotechnology manufacturing expansion in Raritan, NJ. This role involves developing protocols, coordinating with multidisciplinary teams, and supporting qualification of aseptic processing isolators and GMP systems...
- ...Companies is seeking an experienced Commission Qualification Validation Engineer in Raritan, NJ, for an innovative pharmaceutical... ...assisting with IQ/OQ/PQ of new instruments/equipment, ensuring compliance with relevant regulations. Qualified candidates should have...
- ...motivated Senior Quality Validation Specialist, who will contribute... ..., process validation & engineering documents, test protocols,... ...& resolve technical and compliance issues/gaps Provide support... ..., biologics, vaccines, cell or gene therapy operations, including solid...Flexible hours
- Veg Group is seeking a CQV Engineer for a biotechnology manufacturing expansion project in Raritan, NJ. The role will involve supporting commissioning, qualification, and validation for aseptic processing isolators and GMP manufacturing equipment. The ideal candidate should...
- Piper Companies is currently looking for an experienced CQV Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical... ...protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines. Conduct...
- ...Key Responsibilities CQV Execution & Safety - Perform... ...Commissioning, Qualification, and Validation (CQV) activities with a... ...efforts Documentation & Compliance - Support the generation and... ...Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences...For contractorsWorldwide
$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt... ...computer systems, and processes within a cell therapy manufacturing plant in a sterile GMP... ...Responsibilities Provide quality and compliance oversight for computer systems validation...Work at officeFlexible hours- ...joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a C&Q Engineer. Position Type: Contract Onsite... ...Sciences, or similar ~3–8+ years of CQV/Validation experience in pharma/biotech ~ Mandatory...Contract work
- An established industry player is seeking an IT Quality Compliance Specialist/Analyst to ensure regulatory compliance across the product... ...managing the GxP IT Quality Assurance program, reviewing validation deliverables, and supporting inspections. Ideal candidates will...
$107k - $141k
...New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms... ...Biotech is seeking an Associate MES Engineer as part of the Manufacturing... ...to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC,...Temporary workWorldwideFlexible hoursShift work- IT Quality Compliance Specialist/Analyst Hybrid role--Local Candidates Only Work Schedule: Mon - Fri, Business Hours Must have's: Ideal... ...Bonitasoft BPM) Quality assurance mindset for computer system validation for GMP, GDP, GLP space. Regulatory expertise to read and interpret...Local area
- Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle...
- ...1. Technical Responsibilities - Develop documentation for CQV activities - Write and execute protocols (field verification)... ...Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in...Worldwide
- ...highly motivated Senior Process Engineer on our MSAT team who will... ...development of our advanced cell therapy manufacturing platform.... ...development, process transfers, compliance, and scalability for Cellares... ...customers Lead Master Validation Plan creation in order to support...Flexible hours
- ...This has helped us expand into new sectors and steadily grow. Job Description Responsibilities: Investigates and troubleshoots validation problems for equipment and/or performance processes and conducts equipment qualification activities. Conducts analyses of testing...
- Creative Solutions Services, LLC is seeking a qualified candidate for a role focusing on validation in the pharmaceutical industry. Candidates should have over 3 years of experience in Computer System Validation and a strong background in FDA regulations. The position...
- ...Description We are seeking an Automation Engineer to support the development, validation, and day-to-day operation of fully... ...is central to the success of our Cell Q platform and commercial-scale QC... ...integrated technologies for cell therapy manufacturing to accelerate access...Flexible hours
- ...Jersey, seeks a skilled professional to document software and validate specifications for lab instrumentation. Key tasks include gathering... ...skills, along with a detail-oriented approach to ensure compliance with EMA guidelines and internal software management procedures...
$80k - $95k
Description The Maintenance Engineer will take ownership in all the maintenance, troubleshooting... ...excellence, equipment reliability, and compliance with cGMP standards. Essential... ...installation, qualification, and validation (IQ/OQ/PQ) activities, working closely...For contractorsLocal areaFlexible hours- Contract position for a Quality Engineer to achieve ISO 14000 compliance. Primary responsibilities will include: Building / maintaining an EMS (Environmental Management System). Conduct risk assessments. Set environmental objectives & KPIs. Implement corrective and preventive...Contract work
- ...position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-... ..., managing stakeholder communication, and expertise in GxP compliance documentation. The role also requires effective leadership skills...Remote work
- ...Township, NJ, focused on computer system validation. Responsibilities include analyzing... ...Master’s degree in Science, Technology, or Engineering and have relevant experience. This role... ...with offshore teams and ensuring compliance with various standards. #J-18808-Ljbffr...
- Engineering-Resource-Group is seeking a Quality Engineer in Bridgewater Township, NJ, to achieve ISO 14000 compliance. The role involves building and maintaining an Environmental Management System (EMS) along with conducting risk assessments and setting environmental objectives...
- ...and YouTube. Job Description An engineering professional that works with project... ...with commissioning, qualification and validation of new and modified equipment, facilities... ...industries ~ Knowledge of quality / compliance management as well as regulations and standards...Contract workTemporary workLocal areaMonday to FridayNight shiftWeekend work
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