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validation engineers
1 week 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
1 week 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
4 days 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
1 week 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
1 week 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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validation engineers
1 week 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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Product Validation Engineering Technician
2 days 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 ...
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validation engineers
2 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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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 ...
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Validation Engineer
1 week 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
1 week 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
1 week ago
TSR Consulting Summit, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of co ...
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Validation Engineer
3 days ago
System One Holdings, LLC Summit, United StatesJob Title: Validation Engineer · Location: Summit, NJ · Type: Contract · Responsibilities Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification protocols, and associated reports while adhering to a change managemen ...
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Validation Engineer
1 week ago
LanceSoft Summit, United StatesTitle: Engineering - Validation Engineer · Location: Summit NJ 07901 · Duration: 6 months(High Possibility of extension for right candidate) · Comments:100% onsite · Highly preferred cell therapy equipment commissioning qualification. · Must Have: Develops validation/qualificat ...
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Validation Engineer
6 days ago
Yoh, A Day & Zimmermann Company Summit, United StatesJob Description · Job Description Yoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers ...
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Validation Engineer
1 week ago
Mindlance Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. Th ...
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Validation Engineer IV
1 week ago
Katalyst HealthCares & Life Sciences South Plainfield, United States FreelanceResponsibilities: · Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cle ...
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Validation Engineer
1 week ago
Axelon Summit, United StatesJob Description: 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/lab · equipment at multi-use sites through interaction with internal customers and external service · providers. Th ...
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Validation Engineer
1 week ago
Yoh Summit, United StatesYoh is seeking a Validation Engineer for our well established pharmaceutical company. The Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The ...
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Validation Engineer
6 days ago
Cynet Systems Summit, United StatesJob Description: · Pay Range: $79hr - $81hr · Responsibilities: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. · The incumben ...
Validation Engineer - Avenel, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core values.
You will work closely with instrument vendors, facilities, IT, and lab personnel to coordinate the installation and the qualification including computer system validation, of QC Equipment.
Coordinate with laboratory personnel to define qualification requirements.
Author, review, and execute equipment qualification protocols.
Coordinate equipment qualification activities with vendors and other support groups.
Coordinate equipment maintenance activities with vendors and other support groups, as required.
Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
Sign documents for activities as authorized and described by the client's policies, procedures, and job descriptions.
Provide input to technical / investigation reports.
Identify, troubleshoot, and propose a resolution to technical problems.
Receive and provide training.
Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
Coordinate with customers to support multi-site operational activities.
Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
Works to meet schedules and set timelines.
Perform other duties as requested by managers to support Quality activities.
Requirements:
Bachelor's degree (Life Science, Engineering)
Three to six years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing, utility, and automation systems.