computer system validation csv manager Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses ba
Posted 60+ days ago | Updated 1 hour ago

Senior Consultant (Databricks Engineer)

Apex Systems

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Tampa, Florida, USA

Full-time

Job#: 2081041 Job Description: SENIOR CONSULTANT (Databricks Engineer) WHO WE ARE Apex Systems is a leading global technology services firm that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions. We provide a continuum of services, including strategy and enablement, innovation and productivity, and technology foundations to drive better results and bring more value to our clients.?Apex transforms our customers with modern enterprise sol
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Posted 10 days ago | Updated 1 hour ago

Assoc. Spclst , Technical Support

Merck & Company Inc

•

Wilson, North Carolina, USA

Full-time

Job Description Our Digital Manufacturing Operations Team supporting our Wilson, NC site is seeking a Laboratory Systems Support Associate to join our team. This role will provide laboratory system support and expertise to enable our manufacturing and packaging division in the reliable and compliant supply of quality drug/vaccine products to customers and patients across the globe. This job will allow for many opportunities around problem resolution, process/change control, data collection tech
Posted 32 days ago | Updated 1 hour ago

Engineer - Automation/Process - Serialization

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined
Posted 36 days ago | Updated 1 hour ago

Capital Projects IT/OT Compliance Sr. Specialist (Hybrid - West Point, PA)

Merck & Company Inc

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Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuou
Posted 60+ days ago | Updated 1 hour ago

CSV Engineer

Sanofi U.S.

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Swiftwater, Pennsylvania, USA

Full-time

Job Title: CSV Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improv
Posted 56 days ago | Updated 1 hour ago

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Stellent IT LLC

•

Harrisburg, Pennsylvania, USA

Contract, Third Party

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.
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Posted 60+ days ago | Updated 1 day ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 60+ days ago | Updated 1 hour ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 60+ days ago | Updated 1 hour ago

Process Engineer

Novartis

•

Indianapolis, Indiana, USA

Full-time

Job Description Summary The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Supervise plant engineering team providing technical assistance to the function a
Posted 60+ days ago | Updated 1 hour ago

Data Conversion Engineer - Public Safety

Oracle Corporation

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No location provided

Full-time

Job Description Who We Are: The Oracle Local Government Global Industry Unit has launched a modern suite of public safety SaaS applications and hardware for the Local Government markets using cutting edge technologies. These are exciting times in our space - we are growing fast and delivering innovative solutions to public safety agencies. Who You Are: The Public Safety Technical Consultant is a key member of the Oracle Public Safety implementation team responsible for assisting customers in
Posted 16 days ago | Updated 1 hour ago

Data Engineer - Global Membership

Costco Wholesale Corporation

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Issaquah, Washington, USA

Full-time

Costco IT is responsible for the technical future of Costco Wholesale, the third largest retailer in the world with wholesale operations in fourteen countries. Despite our size and explosive international expansion, we continue to provide a family, employee centric atmosphere in which our employees thrive and succeed. This is an environment unlike anything in the high-tech world and the secret of Costco's success is its culture. The value Costco puts on its employees is well documented in artic
Posted 60+ days ago | Updated 1 hour ago

Data Engineer - Costco Travel

Costco Wholesale Corporation

•

Issaquah, Washington, USA

Full-time

Costco Travel IT is responsible for the technical future of Costco Wholesale, the third largest retailer in the world with wholesale operations in fourteen countries. Despite our size and explosive international expansion, we continue to provide a family, employee centric atmosphere in which our employees thrive and succeed. This is an environment unlike anything in the high-tech world and the secret of Costco's success is its culture. The value Costco puts on its employees is well documented i
Posted 60+ days ago | Updated 1 hour ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 31 days ago | Updated 1 hour ago

Principal Engineer, Utilities (Days)

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. T
Posted 7 days ago | Updated 1 hour ago

Automation Engineer - Process

Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and c
Posted 60+ days ago | Updated 1 hour ago

Wireless Research Automation Engineer

Qualcomm Technologies

•

San Diego, California, USA

Full-time

Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > Cellular Technologies General Summary: As a leading technology innovator, Qualcomm pushes the boundaries of what's possible to enable next-generation experiences and drives digital transformation to help create a smarter, connected future for all. As a Qualcomm Software Engineer, you will design, develop, create, modify, and validate embedded and cloud edge software, applications, and/or specialized utility
Posted 60+ days ago | Updated 1 hour ago

Associate Engineer, Facilities & Maintenance

Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 20 days ago | Updated 1 hour ago

Data Engineer

Costco Wholesale Corporation

•

Issaquah, Washington, USA

Full-time

Costco IT is responsible for the technical future of Costco Wholesale, the third largest retailer in the world with wholesale operations in fourteen countries. Despite our size and explosive international expansion, we continue to provide a family, employee centric atmosphere in which our employees thrive and succeed. This is an environment unlike anything in the high-tech world and the secret of Costco's success is its culture. The value Costco puts on its employees is well documented in artic
Posted 60+ days ago | Updated 1 hour ago

Engineer, Facilities & Maintenance

Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f
Posted 22 days ago | Updated 1 hour ago