- Work Location: Piscataway, NJ / East Hanover, NJ
- Reports to: Validation Director
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Validation Engineer
1 week ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
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Validation Engineer
4 weeks ago
Kashiv BioSciences LLC Piscataway, United StatesKey Duties & Responsibilities · Draft and implement Quality System documentation including SOPs and Traceability Matrix designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guideline ...
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Facility Validation Engineer
4 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepa ...
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Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesRoles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...
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Validation Engineer
3 weeks ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
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validation engineers
4 weeks ago
UNITED CONSULTING HUB, INC. Metuchen, United StatesVALIDATION ENGINEERS - UNITED CONSULTING HUB, INC. - METUCHEN, NJ Metuchen, NJ & other unantcpt'd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems for various pharma ...
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Senior Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesMultiple Positions and systems are available: SDMS/Labx/Veeva RIM/SDMS/ValGenesis/Labware LIMS Perform "Data Integrity" related- risk assessments, · Deviation investigations suggest implementing remediations in CGMP operations. · Performs Data Integrity compliance/impact assessm ...
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Sr Associate, Validation Engineer
3 weeks ago
Prostaff Solutions LLC New Brunswick, United StatesJob Description · Job Description Are you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a · Sr. Associate, Validation Engineer · to join their · New Brunswick, New Jersey team . Our client is one of the leading pharm ...
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Sr Associate, Validation Engineer
3 weeks ago
Prostaff Solutions LLC New Brunswick, United StatesAre you looking to be a part of a premier pharmaceutical company? One of our largest clients is currently seeking a · Sr. Associate, Validation Engineer · to join their · New Brunswick, New Jersey team . Our client is one of the leading pharmaceutical companies specializing in ...
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Validation Engineer,packaging
3 weeks ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesRoles&Responsibilities: · Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment that ...
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Validation Engineer
4 days ago
Hyper Recruitment Solutions New York, United StatesValidation Engineer · On-site - New Jersey (Commutable from New York) · Up to $115,000 depending on experience · Sponsorship transfers available for H1B VISA holders · Our client is an established manufacturer who are expanding their US Validation Department. · With exciting pro ...
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Facility Validation Engineer
2 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepare ...
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Validation Engineer
4 weeks ago
Katalyst Healthcares and Life Sciences South Plainfield, United StatesRoles & Responsibilities:Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor and recor ...
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Validation Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences Jersey City, United StatesResponsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (G ...
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Validation Engineer
3 weeks ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesRoles & Responsibilities · : · Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. · Responsible to initiate the preparation and calibration of thermocouple for Kaye AVS/Ellab to monitor ...
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Validation Engineer
3 weeks ago
INTELLECTT INC Iselin, United StatesAnalyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Participate in medical device manuf ...
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validation engineers
1 week ago
INTELLECTT INC Iselin, United StatesManage specification, qualification and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Conduct Risk based ...
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validation engineers
4 weeks ago
INTELLECTT INC Iselin, United StatesVALIDATION ENGINEERS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualfctn & valdtn rqmts. Write & exec engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chngs in Critical to Qlty (CTQs), release of agin ...
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Validation Engineers
3 weeks ago
INTELLECTT INC Iselin, United StatesValidation Engineers - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualification & valdtn rqmts. Write & execute engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chng in Critical to Qlty (CTQs), release ...
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Validation Engineers
4 weeks ago
Shoolin Iselin, United StatesValidation Engineers - Shoolin, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Mng spec, qualification & valdtn rqmts. Write & execute engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chng in Critical to Qlty (CTQs), release of ...
ProBio-Validation Engineer - Piscataway, United States - GenScript
Description
About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology
About GenScript ProBio
GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.
Job Scope:
The position reports to the Validation Director/Manager and is ideally suited for a professional with background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
Position Information:
•Responsible for validation execution and documentation
•Review and approve vendor validation protocols for technical accuracy and compliance
•Execute validation protocols, write validation reports
•Prepare validation protocols where applicable
•Responsible for utility and equipment qualification execution
•Represent QA role in utility, equipment, process and assay validation planning and execution
•Participate in software validation as required
•Interact with functional departments to ensure compliance in validation activities
•Interface with contractors in validation activities
Qualifications:
•BS in life science or related field
•6+ years experience in drug/biologics industry as validation engineer
•4+ years hands on experience in facility, utility, equipment, instrument validation
•Experience in CSV helpful
•Experience in cleaning validation and assay validation a plus
•Familiar with GMP operational principles and documentation
•Works independently, self-motivated, and results oriented
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GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.