computer system validation csv engineer Jobs

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Staff Automation Engineer, Systems

Johnson & Johnson

•

Añasco, Añasco, Puerto Rico

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 14 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev
Posted 60+ days ago | Updated 7 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S
Posted 60+ days ago | Updated 7 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Jacksonville, Florida, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation department.
Posted 60+ days ago | Updated 7 hours ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c
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Posted 60+ days ago | Updated moments ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

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Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee
Posted 60+ days ago | Updated 7 hours ago

Senior Consultant (Databricks Engineer)

Apex Systems

•

Columbus, Ohio, USA

Full-time

Job#: 2080058 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 13 days ago | Updated 6 hours ago

CSV Engineer

Sanofi U.S.

•

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 60+ days ago | Updated 7 hours ago

Senior Consultant (Databricks Engineer)

Apex Systems

•

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 27 days ago | Updated 5 hours ago

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, functions, and uses basi
Posted 60+ days ago | Updated 7 hours ago

Engineer - Automation/Process - Serialization

Eli Lilly and Company

•

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 53 days ago | Updated 7 hours ago

Data Integrity Manager

HAYS

•

Princeton, New Jersey, USA

Contract

Data Integrity Manager - Contract - Princeton, NJ/Hybrid - $64.77 - $64.77/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is
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Posted 56 days ago | Updated 4 hours ago

Staff Automation Engineer, OT and Cybersecurity

Johnson & Johnson

•

Añasco, Añasco, Puerto Rico

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 12 days ago | Updated 7 hours ago

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

Stellent IT LLC

•

Harrisburg, Pennsylvania, USA

Third Party, Contract

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 moments 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 7 hours 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 33 days ago | Updated 7 hours ago

Data Engineer - Global Membership

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 7 hours 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 7 hours ago

Engineer - Serialization Lead, Packaging and Automation

Eli Lilly and Company

•

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 60+ days ago | Updated 7 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

•

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 48 days ago | Updated 7 hours ago