Computer System Validation Jobs in USA, Latest Computer System Validation Jobs in USA

looking for Minimum of 3 years' computer system validation in a pharmaceutical/medical devices environment, including thorough knowledge of regulations and guidelines (21 CFR Part 11, 211, 820, and Annex 11), experience writing VMP, VSR, and IQ/OQ/PQ protocols, and SDLC methodologies (GAMP).Job Summary/DescriptionThis QA Computer System Validation Supervisor provides guidance to Client's Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse or su

The Senior CSV Specialist will work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. Respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based system will produce information or data that meet predefined requirements.RequirementsThis position’s responsibilities will include, but not be limited to the following:- Collaborate with system owner to develop URS, De

- Must be able to plan and lead validation and qualification ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by and the FDA. - Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing

BioPharma Consulting JAD Group has a great position for a CSV Consultant with an industry leader working on site in Lexington, MA. This is a temporary position with the possibility of extension. SUMMARYThis role is responsible to support the GxP digital system lifecycle activities within the Engineering Department. There is no more challenging data environment than Life Sciences due to the integration of scientific research, manufacturing, logistics of pharmaceutical products. Expect to make a

Reporting to the Senior Director, Quality Assurance/Quality Control, the Computer Systems Validation Specialist is responsible for the development, validation and oversight of 21 CFR Part 11 compliance across all GMP electronic systems. The Computer Systems Validation Specialist is an expert in data integrity, electronic documentation, and computer systems validation (CSV).Location: Indianapolis, INIdentify and qualify all computer systems which impact cGMP operations using a risk-based methodol

Hawkins Point Partners is looking for CSV Analyst to join our Quality amp; Compliance team.Person must be a mid- senior level able to independently drive tactical tasks to completion such as developing SOP’s, working with business teams to review vendor documents and complete CSV deliverables. Flexible and able to scale approaches based on phase, risk and business needs. Analytical risk based decision maker able to solution and document decisions using technical writing skills.Requirements- Deve

Hawkins Point is seeking an IT CSV lead for CSV projects executed cross-functional teams that include Business Owners, IT System Administrators and System Owners, and Quality Assurance on projects including on-premises IT infrastructure, cloud infrastructure, enterprise SaaS software, laboratory systems, clinical systems, quality documentation and management systems, and electronic learning management. He/she will partner with IT Operations and Cloud Infrastructure to qualify core network infras

Hawkins Point Partners is looking for CSV Analyst / Business Systems Analyst to join our Quality amp; Validation team.Person must be a mid- senior level able to independently drive tactical tasks to completion such as developing SOP’s, working with business teams to review vendor documents and complete CSV deliverables. Flexible and able to scale approaches based on phase, risk and business needs. Analytical risk-based decision maker able to solution and document decisions using technical writ

Title: Senior Manager, Quality Assurance, Computer System ValidationReporting to: Associate Director, Quality Assurance, Computer System ValidationJob Summary: Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Orchard is a fast-growing and well-funded company with ground-breaking science, a commercial product and a broad pipeline that includes several assets in early

Position SummaryFor decades, Samsung has been leading the charge on innovation. We see beauty in achieving excellence and our passion for change fuels our discoveries, inventions, and breakthrough technology. We believe that technology can, and should, make the world a better place, so we create new possibilities for people everywhere, push the limits of what's possible, and constantly innovate. At Samsung Electronics America, we take pride in the creativity and diversity of our talented peo