- Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
- Performs re-qualification of equipment, facility and utilities as required
- Responsible for creating validation project and validation progress reports - weekly and monthly
- Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements
- Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.
- Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.
- Performs engineering assessment and writes investigation reports for non-conformance
- Assists with engineering projects and performs other duties as assigned.
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Validation Engineer
3 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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Validation Engineer
2 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 Engineer
6 days 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
3 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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ProBio-Validation Engineer
3 weeks ago
GenScript Piscataway, United StatesAbout GenScript · GenScript 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 cat ...
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validation engineers
3 weeks ago
United Pharma Technologies Inc South Plainfield, United StatesVALIDATION ENGINEERS - United Pharma Technologies, Inc. - South Plainfield, NJ So. Plainfield, NJ & other unantcptd locns nationwide. Duties: Analyze validation test data to determine whether systems or processes have met validation criteria & to identify root causes of problems ...
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Facility Validation Engineer
3 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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Facility Validation Engineer
3 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · 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 and execute IQ / OQ / PQ p ...
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Facility Validation Engineer
1 week 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
1 week 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
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
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 ...
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validation engineers
3 weeks ago
Shoolin 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 Engineer
2 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 day 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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Product Validation Engineering Technician
1 week ago
Cummins New York, United States**Product Validation Engineering Technician 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinkers to ...
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Validation Engineers
2 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
3 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
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 ...
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Product Validation Engineering Technician
2 weeks ago
Cummins New York, United States**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
Validation Engineer II - Piscataway, United States - Amneal Pharmaceuticals
Description
:
The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.