Current jobs related to Senior Computer System Validation Engineer - San Diego, California - Capricor Inc
-
Senior Manager of System Validation
4 weeks ago
San Jose, California, United States Super Micro Computer Full timeJob 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...
-
Senior Manager of System Validation
2 months ago
San Jose, California, United States Super Micro Computer Full timeJob 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 Validation Engineer
1 month ago
San Diego, California, United States Precision Medicine Group Full timeAbout Precision Medicine GroupPrecision Medicine Group is a leading advanced therapy technical operations consulting company in the life science industry. Our mission is to advance manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.Job Title: Senior Validation EngineerWe are seeking a highly skilled...
-
Senior System Design Engineer
3 weeks ago
San Jose, California, United States Super Micro Computer Full timeAbout 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...
-
Senior Systems Engineer
1 month ago
San Diego, California, United States STARGATES INC Full timeJob Title: Senior Systems EngineerSTARGATES INC is seeking an experienced Senior Systems Engineer to support the Navy in the areas of systems engineering, requirements definition, systems definition, analysis, and verification and validation for a portfolio of surveillance systems.Key Responsibilities:Support the development and review of system performance...
-
Graphics System/Silicon Validation Engineer
4 weeks ago
San Diego, California, United States Qualcomm Full timeJob 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...
-
Senior Systems Engineer
3 weeks ago
San Diego, California, United States STARGATES INC Full timeJob Title: Senior Systems EngineerSTARGATES INC is seeking a highly experienced Senior Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for supporting the development and review of system performance specifications and system architectures.Key Responsibilities:Apply knowledge of electrical and mechanical...
-
Senior Systems Engineer
3 weeks ago
San Diego, California, United States G2 Ops Inc Full timeJob DescriptionWe are seeking a highly skilled Senior Systems Engineer to join our team at G2 Ops, Inc. in San Diego, CA.The ideal candidate will have a strong background in systems engineering, with experience in model-based systems engineering (MBSE) and a proven track record of delivering complex systems engineering solutions.Responsibilities will...
-
Computer Systems Validation Specialist
4 weeks ago
San Francisco, California, United States CAI Full timeJob 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...
-
Senior Validation Engineer
2 months ago
San Diego, California, United States PSC Biotech Full timeAbout PSC BiotechPSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.Our mission is to empower our clients' success by delivering exceptional services and expertise, leveraging a global team of skilled...
-
Senior Validation Engineer
2 weeks ago
San Diego, California, United States PSC Biotech Full timeJob OverviewPSC Biotech is a leading provider of life sciences services, ensuring the highest standards of product development, manufacturing, and distribution in compliance with regulatory requirements.We are seeking an experienced Senior Validation Engineer to lead the commissioning, qualification, and validation of equipment and systems within the...
-
Senior Verification and Validation Engineer
1 month ago
San Diego, California, United States MILLENNIUMSOFT Full timeJob Title - Senior Verification & Validation EngineerLocation – San Diego, CADuration – 6+ Months ContractTotal Hours/week 1st ShiftDescription:Job Summary:The Senior Verification and Validation Engineer will be responsible for planning, conducting, and reporting on design verification and validation testing within the R&D group of a medical device...
-
Senior Systems Engineer
2 weeks ago
San Diego, California, United States Leidos Full timeJob Summary:Leidos is seeking a Senior Systems Engineer to lead the engineering, design, and implementation of the next generation of cryptographic product security, transport, and accountability for key and data for high and medium assurance applications. This role is located in San Diego, CA.Key Responsibilities:Lead system engineering, hardware, and...
-
Senior Validation Engineer
1 week ago
San Jose, California, United States Saxon Global Full timeJob SummaryAt Saxon Global, we are seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our engineering department, you will be responsible for ensuring the quality and reliability of our products by developing and implementing effective validation strategies.Key Responsibilities• Develop and execute validation plans for...
-
Senior Systems Engineer
2 months ago
San Diego, California, United States Leidos Full timeJob SummaryLeidos is seeking a highly skilled Senior Systems Engineer to lead the engineering, design, and implementation of next-generation cryptographic product security, transport, and accountability for high and medium assurance applications.Key ResponsibilitiesLead system engineering, hardware, and software analysis to support the Navy's Key Management...
-
Senior Computer Systems Architect
3 weeks ago
San Diego, California, United States APR Consulting Full timeJob Summary:We are seeking a highly skilled Senior Computer Systems Architect to join our team in San Diego, CA. As a key member of our Enterprise Architecture team, you will be responsible for designing and implementing complex computer systems, including Linux, Windows, and VMware Virtualization.Key Responsibilities:Design and implement system...
-
Senior Systems Engineer
2 months ago
San Diego, California, United States Leidos Full timeJob SummaryLeidos is seeking a highly skilled Senior Systems Engineer to lead the engineering, design, and implementation of next-generation cryptographic product security, transport, and accountability for high and medium assurance applications.Key ResponsibilitiesLead system engineering, hardware, and software analysis to support the Navy's Key Management...
-
Senior Systems Engineer
1 week ago
San Diego, California, United States Pacira BioSciences, Inc. Full timeAbout Pacira BioSciences, Inc.Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for healthcare practitioners and their patients. Our company has a strong commitment to innovation, with a focus on developing cutting-edge technologies for pain management. We have a...
-
Senior Systems Engineer
1 month ago
San Diego, California, United States Leidos Full timeJob SummaryLeidos is seeking a highly skilled Senior Systems Engineer to lead the engineering, design, and implementation of next-generation cryptographic product security, transport, and accountability for high and medium assurance applications.Key ResponsibilitiesLead system engineering, hardware, and software analysis to support the Navy's Key Management...
-
Senior Systems Engineer
2 weeks ago
San Diego, California, United States The MITRE Corporation Full timeJoin Our Team as a Senior Systems EngineerAt The MITRE Corporation, we're committed to tackling our nation's toughest challenges and making a positive impact on the world. As a Senior Systems Engineer, you'll have the opportunity to work on cutting-edge projects that drive innovation and advancement in the field of C4I systems engineering.Our team is...
Senior Computer System Validation Engineer
2 months ago
Position: Senior Computer System Validation Engineer
Capricor Inc is in search of a diligent and detail-focused Senior Computer System Validation (CSV) Engineer. This role is crucial for ensuring that computerized systems utilized in the biopharmaceutical sector adhere to regulatory standards. The CSV Engineer will take charge of formulating and executing validation protocols, documenting processes, and offering technical guidance to guarantee that systems function efficiently and comply with industry benchmarks.
Key Responsibilities:
- Oversee Data Process Flow Mapping tasks to confirm that all GMP systems align with 21 CFR Part 11 regulations in anticipation of BLA and PLI.
- Ensure the development of Computer System Operation and Administration SOPs for all relevant GMP systems in preparation for BLA and PLI.
- Lead and support Packaging and Label Validation initiatives.
- Create and implement validation protocols (IQ, OQ, PQ) for computerized systems to ensure adherence to regulatory standards (e.g., FDA, GMP).
- Conduct risk assessments and impact analyses concerning system modifications or updates.
- Collaborate with cross-functional teams to establish user requirements and specifications for computer systems.
- Draft and review technical documentation, including validation plans, test scripts, and summary reports.
- Execute testing and document outcomes to verify that systems meet functional and performance criteria.
- Provide technical assistance and direction to project teams throughout the system lifecycle.
- Stay updated on industry trends and regulatory developments to maintain compliance.
- Engage in audits and inspections, addressing findings and implementing corrective measures as necessary.
- Support ongoing improvement initiatives related to CSV processes and practices.
- Other duties as assigned related to computer system validation.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, or a related discipline.
- Minimum of 2 years of proven experience in CSV within a regulated sector (pharmaceuticals, medical devices, etc.).
- Thorough understanding of FDA regulations (21 CFR Part 11, Part 210/211) and GMP guidelines.
- Strong grasp of validation principles, methodologies, and best practices.
- Experience with validation tools and documentation systems (e.g., Document Management Systems, LIMS).
- Exceptional analytical and problem-solving abilities, with a strong attention to detail.
- Effective communication skills, both verbal and written, with the capability to articulate technical information clearly.
- Able to work independently and collaboratively within a team environment.
- Relevant certifications (e.g., Certified Validation Professional) are preferred.
