- Providing support in Quality Assurance process awareness and adherence and supporting in preparation/review process related documents like SOP's (Standard Operating procedures), Work Instructions (WIS) for the support process.
- Experience in UAT, Library and data listings.
- Review of URS document and understand the functionality.
- Responsible for all the validation deliverables as per. compliance.
- Enable change management at the customer, based on change management recommendations.
- Draft, review and execute the IQ/OQ (Test Protocols) scripts.
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Validation Engineer CSV
1 week ago
BlueSky Innovations Tremont City, United StatesWe, the Dr. Franz Köhler Chemie GmbH, are a research-intensive and innovative pharmaceutical company in its third generation with two locations in Bensheim and Alsbach. With a highly specialized portfolio of niche products that require extensive expertise and a great deal of resp ...
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CSV Engineer
2 weeks ago
Mastech Digital Norwood, United StatesCSV ENGINEER (All Visas) · DURATION months · Location: Norwood, MA · Responsibilities will include: · We have a CSV project that is high level that they may be a good fit for. They might need expertise in Hamiltons please verify that they have it if its not on the resume it will ...
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CSV Engineer
1 week ago
DPS Group Global Norwood, United StatesSummary · DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing fa ...
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CSV Engineer
15 hours ago
DPS Group Global Norwood, United StatesSummary · DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing fac ...
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CSV Engineer
1 week ago
DPS Group LLC Devens, United StatesSummary · DPS Group is seeking a CSV (MES) Engineer to support a client in Devens, MA. The candidate must have MES 3.0 and experience in a pharma/biotech GMP Environment. · Responsibilities Provide technical support for ensuring that current versions of the Computer System ar ...
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CSV Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Bridgewater, United StatesResponsibilities: · 7+ years of experience in Computer System Validation · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedu ...
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CSV Engineer
5 days ago
Katalyst Healthcares and Life Sciences Norwood, United StatesResponsibilities:Manage the Computer System Validation aspect of IT projects from software install to business release · Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration. · Responsibility for server instal ...
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CSV Engineer
1 week ago
Katalyst Healthcares and Life Sciences Bridgewater, United StatesResponsibilities: 7+ years of experience in Computer System Validation · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures ...
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Supply Chain Specialist
1 week ago
SMC Ltd. Devens, United StatesSMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing ex ...
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Lead Quality Engineer
1 week ago
OPT Industries Boston, United StatesCompany Description: · OPT Industries () is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, w ...
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CSV Specialist
52 minutes ago
Mentor Technical Group Boston, United StatesJob Description · Job DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensur ...
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Senior Data Enginer
6 days ago
FullStory Boston, United StatesJob Description · Job DescriptionThis role can be performed remotely anywhere within the United States. · Help unlock the secrets hidden in the vast trove of data at Fullstory. We're looking for an experienced Data Engineer to go spelunking through numerous systems and bring orde ...
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Customer Success Manager
1 week ago
Emplifi Boston, United States Full timeAbout Emplifi: · Emplifi is a leading unified customer engagement platform that empowers businesses to reach and grow communities through digital- and social-first strategies. More than 20,000 brands like McDonald's, Ford Motor Company, and Delta Air Lines rely on Emplifi to ena ...
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CSV Specialist
2 weeks ago
Mentor Technical Group Boston, United States Full timeMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, ...
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GxP Validation Engineer/Analyst
4 hours ago
WHITE COLLAR TECHNOLOGIES INC Cambridge, United StatesJob Description · Job DescriptionResponsibilities: · Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new ...
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GxP Validation Engineer/Analyst
2 weeks ago
White Collar Technologies, Inc Cambridge, United StatesJob Description · Job Description · Responsibilities: · Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays o ...
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Validation Specialist
3 days ago
Mentor Technical Group Cambridge, United StatesJob Description · Job DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensur ...
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Lead Quality Engineer
1 week ago
OPT Industries, Inc. Medford, United StatesCompany Description:OPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we de ...
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Lead Quality Engineer
1 week ago
VALID8 Financial Medford, United StatesOPT Industries ) is a rapidly growing, venture-backed MIT spinoff company that focuses on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commerciall ...
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Associate Director, Data Integrity
1 week ago
Viridian Therapeutics Inc. Waltham, United States· At Viridian Therapeutics (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive ...
Sr CSV Engineer - Boston, United States - Maxis Clinical Sciences
Description
Job Description
Job DescriptionSenior Validation Consultant
Must have experience with EDC Validation.
Job Description:
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
Company Description
Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world's 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r\r
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
