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Sr. Validation Engineer(CSV)
3 weeks ago
Katalyst Healthcares and Life Sciences Princeton, 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. · Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP ...
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Computer System Validation Engineer
3 weeks ago
TK-CHAIN LLC Princeton, United StatesResponsibilities · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastru ...
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Computer System Validation Engineer
3 weeks ago
TK-CHAIN LLC Princeton, United StatesResponsibilities · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastruct ...
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Validation Engineer
3 weeks ago
Hyper Recruitment Solutions Ltd Trenton, United StatesJob Reference: · J5638077 · Status: · Under Offer · Updated: · 25/08/2023 · We are currently looking for a Validation Engineer to join a leading Pharmaceutical CDMO company based in the New Jersey area. As the Validation Engineer you will be responsible for a range of activiti ...
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Validation Engineer
1 week ago
Acara Solutions, An Aleron Company Trenton, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
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Validation Engineer
1 week ago
ComforceHealth Trenton, United StatesJob ID: · Summit , · New Jersey · Job Type: · Contract · Added - 05/08/24 · Job Description · Innova Solutions is immediately hiring for a · Validation Engineer · Position type: Full-time Contract · Duration: · 06 Months · Location: · Summit, NJ Onsite) · As a · Valid ...
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Artech Summit, United StatesValidation Engineer Pharmaceutical · Summit, NJ · 100% onsite · Duration: 6 months(High Possibility of extension for right candidate) · Highly preferred cell therapy equipment commissioning qualification. · Must Have: Develops validation/qualification deliverables such as Validat ...
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Artech Summit, United StatesValidation Engineer Pharmaceutical · Summit, NJ · 100% onsite · Duration: 6 months(High Possibility of extension for right candidate) · Highly preferred cell therapy equipment commissioning qualification. · Must Have: Develops validation/qualification deliverables such as Validat ...
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Sunrise Systems Summit, United StatesJob Title: Validation Engineer · Job ID:(phone number removed) · Location: Summit, NJ, 07901 · Duration: 06 Months contract on W2 · 100% Onsite position · PURPOSE AND SCOPE OF POSITION: · The Equipment Validation Engineer supports the successful implementation of various process/ ...
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Validation Engineer
3 weeks ago
Colsh Consultants LLC. Trenton, United States· • Own and manage the Information Protection and RiskManagement (IPRM) Processes such as Compliance Solution Profile (CRP)assessment, Data Integrity and Electronic Record Electronic Signature (ERES)assessments and Supplier Control Assessment Process for software solutions. · • ...
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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
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
3 weeks ago
Joulé Warminster, United StatesTitle: Automation Validation Engineer - Pharmaceutical · Location: Warminster, PA · Type: 6 Month Contract potential for extension or hire · Schedule: Mon-Fri Day · Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develo ...
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Validation Engineer
1 week ago
Innova Solutions Summit, United StatesInnova Solutions is immediately hiring for a Validation Engineer · Position type: Full-time Contract · Duration: 06 Months · Location: Summit, NJ Onsite) · As a Validation Engineer, you will: · The Equipment Validation Engineer supports the successful implementation of various pr ...
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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 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
1 week ago
System One Warminster, United StatesTitle: · Automation Validation Engineer - Pharmaceutical · Location: · Warminster, PA · Type: · 6 Month Contract potential for extension or hire · Schedule: · Mon-Fri Day · Overview: · Growing Pharmaceutical Company is seeking an Automation Validation Engineering Profession ...
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Validation Engineer
6 days 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
1 week ago
On-Board Companies Summit, United StatesOn-Board Services is hiring a Validation Engineer in Summit, NJ · For immediate consideration please send your resume to · Subject Line: Position Title and State you are Located · About Us: · On-Board Services, Incorporated is an on-site contract service provider for a local man ...
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Validation Engineer
3 weeks ago
PAREXEL Horsham, United States Local OfficeWe are looking to fill a position for a Validation Engineer - Laboratory working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid tim ...
Computer System Validation Engineer - Princeton, United States - TK-CHAIN LLC
Description
Job Description
Job DescriptionResponsibilities
Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
Perform testing of the entire SDLC, including version/change control and new software rollouts.
Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.
Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.
Author IQ/OQ protocols for new or used equipment purchased.Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.
Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISORequirements
BS in Engineering, Science, or equivalent technical degree.
7+ years experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
Excellent written and verbal communication skills; excellent technical writing skills.
Strong interpersonal skills and the ability to work in a team environment.
Ability to work effectively in a fast-paced multitasking environment.
Strong working knowledge of FDA and cGMP regulations and documentation practices.
Proficient in Microsoft Word, Excel, PowerPoint.