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Validation Engineer
4 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
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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Validation Engineer II
1 week ago
Amneal Pharmaceuticals Piscataway, United States: · The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes. · Essential Functions: · + Design, review and execute validation docume ...
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ProBio-Validation Engineer
1 week 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 Engineer I, Engineering
2 weeks ago
Amneal Pharmaceuticals Piscataway, United StatesJob Summary · The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. · Essential Functions · + Assist in the preparation/ exec ...
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validation engineers
1 week 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
1 week 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: · Prepa ...
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Validation Engineer
5 days 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 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
5 days 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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computer systems validation engineers
1 week ago
National Computer Systems Piscataway, United StatesJobs · > · COMPUTER SYSTEMS VALIDATION ENGINEERS · COMPUTER SYSTEMS VALIDATION ENGINEERS · NCS AT 21 · Job Description: · Understand and analyze requirements, define tasks and execute them. Involve in preparing documentation for all aspects of the computer system validation li ...
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Validation Engineers
1 day 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 Engineer/Specialist
1 week ago
IPS-Integrated Project Services, LLC Somerset, United StatesJob Description: · At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Validation Engineer/Specialist to join our talented team at our office located ...
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Sr Associate, Validation Engineer
1 week 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 developin ...
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Sr Associate, Validation Engineer
6 days 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 developin ...
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Sr Associate, Validation Engineer
5 days 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 ...
Validation Engineer - Piscataway, United States - Kashiv BioSciences LLC
Description
Key Duties & ResponsibilitiesDraft 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 guidelines and internal quality standards.Coordinate all validation activities with vendors, analyze and assemble results, and draft validation reports.
Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies.
Requirements
Knowledge and Skills:
Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc) Understanding of c.
P principles and familiarization with ISO guidelines.
Working knowledge of Computer Systems Validation lifecycle and documentation.
Proficient in Microsoft Word, Excel, PowerPoint.
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
Must demonstrate strong communication, interpersonal and teamwork skills.
A strong understanding of technical writing and presentation skills is required.
Educations and Experience:
Degree in engineering / Pharmaceuticals or another relevant discipline.
Minimum of 4+ years (BS) or 2+ years (MS) of experience working within a medical device environment or other FDA regulated environments.
Experience with Biological products is highly desirable.#J-18808-Ljbffr
