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Computer System Validation (CSV) Engineer

Jobot

Scottsdale, Arizona, USA

Full-time

Computer System Validation (CSV) Engineer with strong knowledge of FDA and cGMP regulations and documentation practices and 21 CFR Part 11. needed! (**Full relocation provided**) This Jobot Job is hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $145,000 per year A bit about us: We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering

Computer System Validation Specialist

SGS Consulting

Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r

Engineering Specialist III

Arthur Lawrence

Mooresville, Indiana, USA

Contract

Arthur Lawrence is looking to hire an Engineering Specialist for one of our clients in Mooresville, IN, WA. Please find the job description below and send us your updated resume, if interested: Must-Have Skills: Hands-on with PLC systems (preferably Siemens), including troubleshooting, and configuration Skilled in Computer System Validation (CSV) and FDA regulations (21 CFR Part 11, GMP) Experienced in project management, stakeholder engagement experience, also with ISA 95 and S88 standards Nic

Business Analyst

Intelliswift Software Inc

South San Francisco, California, USA

Contract

Job Title: Business Analyst Duration: 6 Months Location: South San Francisco, CA, USA Pay Range: $80 per hour Intelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT and Talent solutions. We specialize in delivering world-class Digital Product Engineering, Data Management and Analytics, and Staffing Soluti

GMP, LIMS, Wet Lab and Pharma Manuf Analyst Cell and Gene Therapy

CSI (Consultant Specialists Inc.)

South San Francisco, California, USA

Contract

Very proactive, experience working with data systems that produce data, experience around manufacturing Understanding of the needs and operations of a Wet lab, including ELN and LIMS systems Experience implementing IT solutions that need GMP validation Experience working in an agile development team Familiarity with agile methods and tools like User Stories, Story Maps, and Personas Description: BA, Clinical Stage Cell Therapy Process & Analytical Development - Data and Analytics The Business

BioInformatics Analyst Genomics, GxP

CSI (Consultant Specialists Inc.)

South San Francisco, California, USA

Contract

W2 ONLY. Remote OK. No C2C. No 3rd Parties, No Exceptions.DescriptionBusiness Analyst - BioInformatics The Business Analyst (BA) is a self-motivated expert in business analysis who is passionate about improving healthcare. They are flexible and dedicated to providing value to patients. The BA must be good at negotiating, leading, and communicating when working with the Cell and Gene Therapy business unit and with IT teams. The BA will collaborate with one or more internal business groups and IT

CSV Analyst/Technical Writer

TEKsystems c/o Allegis Group

Indianapolis, Indiana, USA

Full-time

Seeking a Technical Writer/ CSV Analyst Position Overview: Experienced Technical Writer with a focus on system validation, specifically around validating IT systems, to support the large molecule group in documenting validation processes for their Electronic Lab Notebook (ELN) system. This role emphasizes the importance of Computer System Validation (CSV) experience and requires the candidate to work independently while engaging with multiple stakeholders, including IT, R&D, Quality & Validation

IT Client Site Support ( NPHS Manufacturing)

Cardinal Health

Indianapolis, Indiana, USA

Full-time

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500. Information Technology oversees the effective development, delivery, and opera

Code Data Validation Consultant (Machine Learning & Data Processing)

U.S. Tech Solutions Inc.

San Jose, California, USA

Contract

Job Description: Join our team to enable cutting-edge AI/ML innovation by building robust data pipelines and automation tools.You ll work closely with human data operators and generative AI teams to process, analyze, and optimize high-quality datasets for training machine learning models.Your work will directly impact the efficiency and performance of AI systems, from automating data quality checks to designing infrastructure that scales with evolving model requirements.This role is ideal for a

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.

Quality Assurance Engineer - CSV

Civica Rx

Petersburg, Virginia, USA

Full-time

About Civica: Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, near

SAP Ariba Senior Integration Consultant (US based)

SAP Americas, Inc.

Plano, Texas, USA

Full-time

We help the world run better At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative, caring team environment with a strong focus on learning and development, recognition for your i

Associate Director, IT Quality

Regeneron Pharmaceutical

Troy, New York, USA

Full-time

We are currently looking to fill a Associate Director, IT Quality position. This position will be responsible for providing leadership and functional oversight for quality operations supporting IT and IS globally at Regeneron's facilities. In this role, a typical day might include the following: Develop and maintain an industry leading approach to computer systems validation.Lead the development of processes and systems that drive compliance to critical regulatory requirements specific to IT sy

Technical System Owner

Apex Systems

Lexington, Massachusetts, USA

Full-time

Job#: 2070937 Job Description: Technical System Owner opening in Lexington, MA. area! Apex Systems is a world-class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions. Apex has an opportunity to be a Technical System Owner in the Boston area. This is a contract-to-hire position, and the pay rate is flexible depending on your experience. Here are the details: For applicants interested in this Technical Sy

Senior Validation Engineer

Thermo Fisher Scientific

Allentown, Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific, Inc. LOCATION: 7554 Schantz Rd., Allentown, PA 18106 TITLE: Senior Validation Engineer HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Provide validation support to validate computer systems, equipment and equipment systems, and critical utilities and facilities required for packaging operations. Ensure site compliance and all necessary activities are performed on time t

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

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

Automation Engineer

Novartis

Indianapolis, Indiana, USA

Full-time

Job Description Summary The Automation Engineer will provide support for automation systems, interfaces and equipment. Responsible for oversight of the automation systems across the facility (building/process/laboratory). Ensures the site's compliance with internal GMP's, CSV and external regulatory requirements. Job Description 766 million. That's how many lives our products touch. At Novartis, being there when and how it matters most for our patients and customers allows us to live our purpo

Project Manager-Business Capability

HAYS

Princeton, New Jersey, USA

Contract

Project Manager-Business Capability - Contract - Princeton, NJ/Hybrid - $94.41 - $94.41/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. O

Senior Engineer, Facilities & Maintenance CLT

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