Computer System Validation Lead

1 week ago

San Mateo, California, United States TechnoGen Inc Full time
Job Description

We are seeking a highly experienced CSV Lead to join our team at TechnoGen Inc. The ideal candidate will have a strong background in Computer System Validation, GMP experience, and a proven track record of delivering high-quality CSV deliverables.

Key Responsibilities:

  • Develop and implement effective CSV delivery models, including the creation of templates, training courses, and KPI metrics.
  • Provide thought leadership on GMP Systems, working across departments to deliver CSV-related programs, innovations, and communications.
  • Contribute to operational and process improvement initiatives related to Quality and Compliance.
  • Apply CSV expertise to drive business value in a specific department or business unit.
  • Interpret and execute company policies and procedures, recommending modifications as needed.
  • Develop validation testing strategies in accordance with Gilead's policies and procedures.
  • Collaborate with validation team members to ensure system impact is assessed and mitigation strategies are in place.
  • Partner with the business to ensure CSV methodologies are well understood and applied effectively.
  • Learn and become proficient in EDMS and ELMS systems for document review, approval, and training.
  • Prepare, revise, and obtain approval of GMP laboratory-related documents, including SOPs, WIs, Forms, User Manuals, and Training Plans.

Requirements:

  • Minimum 10+ years of experience in CSV and GMP Pharmaceutical/Biotechnology/Medical Device environment.
  • Advanced knowledge of Computer System Validation, FDA, and international requirements, including Part 11.
  • Experience writing validation deliverables per GAMP guidelines.
  • Ability to master technical content through interaction with subject matter experts.
  • Laboratory experience as a chemist or microbiologist is preferred.
  • Understanding of programming and relational database concepts is required.
  • BA/BS degree in relevant disciplines is preferred.

  • Computer Systems Validation Lead

    2 weeks ago

    San Francisco, California, United States RxCloud Full time

    About the role: Computer Systems Validation LeadRxCloud is seeking an experienced Computer Systems Validation Lead to join our team. As a key member of our quality assurance team, you will be responsible for developing and implementing scalable validation strategies, documents, and performing document reviews.Key responsibilities:Develop full validation...

  • Computer Systems Validation Lead

    4 weeks ago

    San Francisco, California, United States RxCloud Full time

    About the JobAt RxCloud, we are seeking a highly experienced Computer Systems Validation Lead to join our team. As a key member of our validation team, you will be responsible for developing and implementing scalable validation strategies, documents, and protocols to ensure continuous compliance with GMP/GxP regulations.Key ResponsibilitiesDevelop and...

  • Senior Manager of System Validation

    1 month ago

    San Jose, California, United States Super Micro Computer Full time

    Job SummarySuper Micro Computer, Inc. is seeking a highly skilled Sr. Manager, System Validation to lead the Validation team in Server Production. The successful candidate will be responsible for managing and mentoring the team to ensure the delivery of high-quality server products.Key ResponsibilitiesManage, lead, and build a high-performing...

  • Senior Manager of System Validation

    4 weeks ago

    San Jose, California, United States Super Micro Computer Full time

    Job SummarySuper Micro Computer, Inc. is seeking a highly skilled Senior Manager, System Validation to lead the Validation team in Server Production. The successful candidate will be responsible for managing and mentoring the team to ensure the delivery of high-quality server products, as expected by the management team.Key ResponsibilitiesManage, lead, and...

  • Computer Systems Validation Specialist

    2 weeks ago

    San Francisco, California, United States RxCloud Full time

    About the JobAt RxCloud, we are seeking a highly experienced Computer Systems Validation Lead to join our team. The ideal candidate will have a strong background in computer systems validation, with a minimum of 10 years of experience in supporting and/or performing all aspects of computer systems validation activities.Key Responsibilities:Develop scalable...

  • Computer Systems Validation Expert

    5 days ago

    San Francisco, California, United States RxCloud Full time

    About the RoleAt RxCloud, we're seeking a seasoned Computer Systems Validation Lead to support and perform all aspects of computer systems validation activities. This includes developing scalable validation strategies, documents, and performing document reviews. The ideal candidate will have at least 10 years of experience in this field, with a minimum of 7...

  • Senior Manager of System Validation

    3 weeks ago

    San Jose, California, United States Super Micro Computer Full time

    Job Summary:Super Micro Computer, Inc. is on the lookout for a Senior Manager of System Validation to oversee the Validation team within Server Production. This role entails managing and mentoring the team responsible for testing server products and developing comprehensive test plans to ensure the highest quality standards are met.Key Responsibilities:As a...

  • Computer Systems Validation Specialist

    3 weeks ago

    San Francisco, California, United States CAI Full time

    Job Title: Computer Systems Validation EngineerWe are seeking a highly skilled Computer Systems Validation Engineer to join our team at CAI. As a key member of our team, you will be responsible for developing and executing protocols and test scripts to ensure the validation of computer systems.Key Responsibilities:Develop and execute protocols and test...

  • Computer Systems Validation Specialist

    4 days ago

    San Francisco, California, United States Katalyst Healthcares and Life Sciences Full time

    Job Title: Computer Systems Validation SpecialistAbout the Role:Katalyst Healthcares and Life Sciences is seeking a skilled Computer Systems Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.Key Responsibilities:Apply...

  • Associate Director, Quality Assurance Computer Systems Validation

    1 month ago

    San Diego, California, United States Arrowhead Pharmaceuticals Full time

    Job Title: Associate Director, QA Computer Systems ValidationArrowhead Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking an experienced Associate Director to lead our Quality Assurance (QA) Computer Systems Validation (CSV) program.Key Responsibilities:Develop...

  • Validation Specialist

    2 weeks ago

    San Mateo, California, United States Fladger Assoc. Inc. Full time

    Job DescriptionFladger Assoc. Inc. is seeking a skilled Validation Specialist to join our team in Santa Monica, CA.As a Validation Specialist, you will be responsible for performing the validation of computer systems, including developing validation master plans, preparing protocols, analyzing test results, and preparing technical reports.Key...

  • SAP Validation and QA Lead

    1 week ago

    San Mateo, California, United States Katalyst Healthcares & Life Sciences Full time

    Job SummaryWe are seeking a highly skilled SAP Validation and QA Lead to join our team at Katalyst Healthcares & Life Sciences. The ideal candidate will have strong functional knowledge of Validation and QA for pharmaceutical or biotech, as well as experience with SAP S/4 implementation. This role requires effective communication skills to work with business...

  • Manager, Validation Lead

    4 days ago

    San Francisco, California, United States Daiichi Sankyo, Inc. Full time

    Legacy of InnovationDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve global healthcare standards. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees worldwide draw upon a rich legacy of innovation and a robust pipeline of...

  • SERDES System Validation Engineer

    1 month ago

    San Jose, California, United States Cadence Design Systems Full time

    Job Title: SERDES System Validation EngineerCadence Design Systems is seeking an experienced SERDES System Validation Engineer to join our team in San Jose, California. As a key member of our R&D team, you will be responsible for the technical validation of high-speed interfaces on complex emulation processing ASICs and FPGAs.Key Responsibilities:Develop and...

  • Senior System Design Engineer

    2 weeks ago

    San Jose, California, United States Super Micro Computer Full time

    About SupermicroSupermicro is a leading provider of advanced server, storage, and networking solutions for data center, cloud computing, enterprise IT, Hadoop/Big Data, Hyperscale, HPC, and IoT/embedded customers worldwide.We are a fast-growing company with a strong presence in the technology industry.Job SummaryThe product team at Supermicro is seeking an...

  • Lead Systems Engineer in Medical Robotics

    2 months ago

    San Mateo, California, United States Ruby Robotics Full time

    Position: Senior Systems Engineer - Ruby RoboticsCompany Overview: Ruby Robotics is at the forefront of enhancing precision oncology through innovative robotics and artificial intelligence technologies. Founded by alumni from Stanford and MIT, who have successfully launched multiple medical device companies, our flagship product employs a unique instrument...

  • Finance Systems Lead

    2 weeks ago

    San Mateo, California, United States Roblox Full time

    Join Our Team as a Finance Systems LeadWe are seeking a highly skilled Finance Systems Lead to join our team at Roblox. As a key member of our Finance team, you will be responsible for designing and building complex financial models in our Enterprise Performance Management (EPM) tool. Your expertise will help us drive business growth and improve financial...

  • Graphics System/Silicon Validation Engineer

    3 weeks ago

    San Diego, California, United States Qualcomm Full time

    Job SummaryWe are seeking a highly skilled Silicon Validation Engineer to join our team at Qualcomm. As a member of our Graphics Post-silicon team, you will be responsible for ensuring the successful commercialization of our GPU in next-generation chips.Key ResponsibilitiesDevelop and execute system-level validation plans to ensure the quality and...

  • High-Speed System Validation Engineer

    5 days ago

    San Jose, California, United States Cadence Design Systems Full time

    Job SummaryCadence Design Systems is seeking a highly skilled High-Speed System Validation Engineer to join our team. As a key member of our R&D organization, you will be responsible for the validation of complex high-performance emulation processing ASICs and FPGAs. Your expertise in high-speed system design and SI/PI budgeting methodology will be crucial...

  • Regulatory Compliance Specialist for Computer Systems

    3 days ago

    San Francisco, California, United States Katalyst Healthcares and Life Sciences Full time

    We're seeking a highly skilled Regulatory Compliance Specialist for Computer Systems to join Katalyst Healthcares and Life Sciences. This exciting opportunity will allow you to utilize your expertise in 21CFR Part 11 systems validation and regulatory compliance to ensure the highest standards of quality and safety in our computerized systems.About UsKatalyst...