CSV Consultant (Computer System Validation)
Stark Pharma
Job Title: CSV Consultant (Computer Systems Validation) Location: Redwood City, CA Type: Contract Job Summary We are seeking an experienced CSV Consultant to support validation activities across multiple GxP-regulated systems within a pharmaceutical environment. This role will focus on computer systems validation, revalidation efforts, data migration activities, and documentation management for critical business and quality systems. The ideal candidate will have strong experience with validated systems, change control processes, and regulatory compliance in GMP/GxP environments. Key Responsibilities Lead and support validation activities for GxP-regulated systems including: SAS Studio Veeva Quality Docs CTMS TraceLink Argus Support system revalidation and data migration projects to ensure compliance and data integrity Develop, review, and execute validation documentation including: Validation Plans User Requirements Specifications (URS) Risk Assessments IQ/OQ/PQ protocols Traceability Matrices Summary Reports Create and support User Acceptance Testing (UAT) scripts and execution activities Manage change control documentation and support deviation resolution activities Ensure validation activities align with FDA, GAMP5, and GxP compliance requirements Collaborate with IT, Quality, Clinical, and Business stakeholders to support validated system implementations and updates Maintain accurate and compliant documentation throughout the system lifecycle Required Qualifications Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field 5+ years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environments Hands‑on experience validating GxP systems and supporting regulated system implementations Strong knowledge of FDA 21 CFR Part 11, GAMP5, and GxP requirements Experience with validation documentation, UAT execution, and change control processes Familiarity with systems such as SAS Studio, Veeva, CTMS, TraceLink, or Argus Strong analytical, documentation, and communication skills #J-18808-Ljbffr Stark Pharma
- Stark Pharma is looking for an experienced CSV Consultant in Redwood City, CA to support validation activities across GxP-regulated systems in a pharmaceutical environment. The... ...will have over 5 years of experience in Computer Systems Validation, with hands-on experience...Computer
$164k - $205k
Revolution Medicines, located in Redwood City, CA, is seeking a Quality Assurance professional to oversee Computer System Validation (CSV) activities. The role demands a strong background in GxP regulations and experience in the pharmaceutical industry, ensuring compliance...Computer$164k - $205k
...tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity Serve as the Computer System Validation (CSV) QA subject matter expert and provide guidance on the interpretation and application of global GxP regulations and...Computer- A biopharmaceutical company based in Redwood City, CA is seeking a Manager for IT Business Systems Quality. This role entails managing Computer System Validation activities and ensuring compliance with GxP standards. The ideal candidate will have a Bachelor’s degree in...Computer
- ...Senior GxP Systems & Validation Specialist Our client, a world leader in life sciences and biotechnology, is looking for a Senior... ...compliant, reliable, and efficient systems through Computer System Validation (CSV), infrastructure support, quality event management, and...ComputerLong term contract
Dawar Consulting
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National Guard OMD
San Mateo, CA3 days ago - ...documentation within the CRM and internal tracking systems.? ? 4. Cross-Functional... ...Use of equipment such Printers, Scanners, Computers etc. Frequent occasional stand/walk, reach... ...(DOJ, CACI & FBI).? Valid Drivers License (if transporting children...ComputerInterim roleCasual workWork at officeLocal area
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...develop and execute test methodologies for verification and validation of autonomous hardware systems and components. Collaborate with and influence key... ...Bachelor's degree in Electrical Engineering, Computer Engineering or a related field. 7+ years of proven experience...ComputerLocal area$65k - $144k
Join to apply for the Surgical Consultant role at Pacific Medical, Inc.... ...data into the PacMed Medep system or other designated systems... ...house product training program Computer proficiency (fax, modem,... ...Overnight travel up to 20% annually Valid driver’s license Strong...ComputerFull timeImmediate startNight shift- Position: Manager - IT Business Systems Quality Location: Redwood City, CA Job Id: 249-1135 # of Openings: 1 Manager -... ...business capabilities. You will also manage and support Computer System Validation (CSV) activities. The successful candidate must be an experienced...Computer
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Position Summary As a Staff Solution Consultant, you will leverage deep business... ...Lead user acceptance testing and validate solution functionality across... ...Qualifications Bachelor’s degree in computer science, management, information systems, mathematics, business, or...ComputerFull timeTemporary workPart timeWork experience placementLocal area$101.64k - $152.46k
...automation transformation and related validation activities. The first two... ...of digital tools (MES systems, software, etc) and may require... ...integrity and validation of computer systems meet all applicable industry... ...developing and leading CSV and Life‑cycle management activities...ComputerHourly payContract workTemporary workAstraZeneca
Redwood City, CA4 days ago- ...searches and freedom-to-operate analyses. Evaluate patentability, validity, and infringement risks of scientific inventions. Support IP... ...examination if not already registered. Education Bachelor's degree in Computer Science, Computer Engineering, Software Engineering, or...ComputerWork at office
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...general nature, level and purpose of the job. The lactation consultants work in the inpatient setting. Work collaboratively with... ...provide leadership and influence others. * Knowledge of computer systems and software used in functional area. PHYSICAL REQUIREMENTS...ComputerHourly payPart timeRemote workShift workAfternoon shiftStanford Medicine Children's Health
Palo Alto, CA1 day ago$36.5 - $42.25 per hour
...activities on test equipment and data acquisition systems Use mechanical hand tools and torque... ..., GED or equivalent Must possess a valid state issued driver's license Ability to... ...Ability to lift 50 lbs to chest height Computer experience for input and retrieval of data...ComputerWork at officeFlexible hours$120k - $160k
...recruiting for a Verification and Verification Systems Engineer who will support the system... ...Define and implement verification and validation methods across multiple test... ...Robotics, MechE/EE, System Engineering, Computer Science or a related STEM field. Strong...ComputerPermanent employmentWork at officeRemote workVisa sponsorshipFlexible hours- ...a talented team, securing capital, and validating our technology. We are now seeking passionate... ...-quality, real-world data collection system. At the same time, we’re building a new... ...-drive actuators Experience calibrating computer vision systems At Sunday Robotics, we’re...Computer
Sunday
Redwood City, CA2 days ago $18.7 - $23.35 per hour
...Ensures new products are properly merchandised and represented in a timely manner. Correctly enters all receiving documents into the computer system, reconciles merchandise invoices to items received as applicable. Accurately and timely completes store-to-store transfers and...ComputerLocal areaFlexible hoursShift workNight shiftChico's
Los Altos, CA4 days ago- ...founding engineer to drive the core ML and AI systems that power the product. Role Overview... ..., preprocessing, model training, validation, and deployment. Design real-time inference... ...Industries Software Development and Computer and Network Security #J-18808-Ljbffr Greylock...ComputerFull timeImmediate start
$17.95 - $22.5 per hour
...Ensures new products are properly merchandised and represented in a timely manner. Correctly enters all receiving documents into the computer system, reconciles merchandise invoices to items received as applicable. Accurately and timely completes store-to-store transfers and...ComputerLocal areaFlexible hoursShift workNight shiftChico's
San Mateo, CA4 days ago$18.7 - $23.35 per hour
...Ensures new products are properly merchandised and represented in a timely manner. Correctly enters all receiving documents into the computer system, reconciles merchandise invoices to items received as applicable. Accurately and timely completes store-to-store transfers and...ComputerLocal areaFlexible hoursShift workNight shiftChico's FAS
Los Altos, CA4 days ago- ...issues, supporting end-user devices and applications, maintaining system availability, and contributing to a high level of IT service... ...preferred. Experience Bachelor's degree in Information Technology, Computer Science, or related field preferred; equivalent experience...ComputerWork at office
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- ...Prosecution Associate for their Redwood City, CA office. The ideal candidate will possess expertise in Electrical Engineering or Computer Science along with Japanese language skills. You will be responsible for conducting patent prosecution, advising on intellectual property...ComputerWork at officeFlexible hours
- ...legal work. Requirements Minimum of 2 years of experience in patent prosecution and counseling. Degree in electrical engineering, computer engineering, applied physics, computer science, or equivalent experience. Law degree from an ABA-accredited law school. U.S. bar membership...ComputerWork at officeRelocation package
- ...potential through hands-on training with legal teams. The ideal candidate will have a Bachelor's degree in Electrical Engineering, Computer Science, or Mechanical Engineering, proficiency in English and Japanese, and at least 2 years of patent prosecution experience....ComputerFlexible hours
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