CSV Engineer
Katalyst HealthCares & Life Sciences
Job-ID32797346Reference26-01367Roles & Responsibilities:Develop and implement validation strategies for computer systems and software applications. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports. Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems. Conduct validation testing and review test results to ensure systems meet specified requirements. Provide training and support to staff on validation processes and procedures. Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance. Participate in audits and inspections by regulatory agencies. Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS. Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards Assist site Automation groups in configuring I/O and executing CSV protocol requirements. Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report Requirements: Bachelor's degree in Computer Science, Engineering, or a related field. Minimum of 2-5 years of experience in computer system validation or a related field. Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5). Experience with validation of various types of systems, including ERP, LIMS, and MES. Excellent documentation and technical writing skills. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team. Excellent communication and interpersonal skills. Preferred: Certification in Computer System Validation or related areas. Experience with cloud-based systems and software validation, experience with Blue Mountain RAM. 3+ years of work experience with Computer System Validation. 3+ years of Biotechnology Research experience.
$160k - $252.5k
...for the "architects of the electron" to help us make fossil-fuel peaker plants a thing of the past. Power Electronics Controls Engineer As a Power Electronics Controls Engineer, you will lead the design and implementation of the intelligent "brains" for our next-...SuggestedFull timeShift work- ...America Mission Critical - Building Commissioning /Full Time /HybridWe are seeking a highly skilled and detail-oriented Commissioning Engineer to join our team. As a Commissioning Engineer, you will play a crucial role in ensuring the successful installation, startup, and...SuggestedFull timeWorldwide
$129.5k - $145k
...be on the front lines of this massive shift.WHY BOX NEEDS YOU We are looking for an experienced and driven GRC Controls Automation Engineer who is looking to put their demonstrated awareness of regulatory standards to help bridge compliance requirements, technical...SuggestedLive inWork at officeShift work3 days per week$112k - $135k
Overview Shimmick is seeking an experienced Field Engineer to support the Vista Grande Drainage Basin Improvements Project in Daly City, CA.Backed by over 100 years of expertise and driven by innovation and an entrepreneurial spirit, Shimmick is one of the most dynamic...SuggestedFull timeContract workTemporary workFor subcontractorWork at officeFlexible hours- Tetra Tech currently has an opening for an Automation Engineer to join our Systems Integration team. Hybrid work is expected to be completed at various client sites around the San Jose, CA area. This position supports Tetra Tech’s municipal and industrial water and wastewater...SuggestedWork at officeLocal areaNight shift
- ...everyone to get stuck into. And that’s where you come in.DescriptionHitachi Rail is looking for an enthusiastic self-motivated Project Engineer Construction who thrives in a fast-paced environment. The successful candidate is comfortable performing a wide range of tasks...For subcontractor
$206.4k - $379.1k
...Adobe Firefly’s Generative AI Services team is seeking a Principal Service Engineer to serve as the technical lead for our GenAI Services domain. In this high-impact role, you will lead a team of talented engineers in building scalable, high-performance generative AI...Full timeTemporary workLocal areaWorldwide$115k - $150k
...million from some of the world’s best investors, from Andreessen Horowitz to Blackrock and Fidelity, and employs a team of 450 engineers and entrepreneurs. Astranis designs, builds, and operates its satellites out of its 153,000 sq. ft. headquarters in Northern California...Permanent employmentFull timeFlexible hours- ...into. And that’s where you come in.DescriptionHitachi Rail is looking for an enthusiastic self-motivated Principal Commissioning Engineer who thrives in a fast-paced environment. The successful candidate is comfortable performing a wide range of tasks from administrative...Work at office
$196k - $248k
...autonomously driving over 100 million miles on public roads and tens of billions in simulation across 15+ U.S. states. Waymo's Systems Engineering team works together to blend software and hardware systems in groundbreaking new ways. We set the high performance standards...Full timeRemote work$117.8k - $176.8k
...transformational projects that will benefit future generations. Grow with us, H2O+U.Stantec is currently seeking an Instrumentation and Controls Engineer for any one of our California state office locations - San Francisco, Irvine or Sacramento.Successful applicant will work with a...Full timeContract workTemporary workPart timeFor contractorsCasual workWork at officeLocal areaFlexible hours- ...the goal of creating the best customer service experience for our users. The Difference You Will Make: As a staff software engineer, you will lead two areas that are critical to Airbnb community support: Automation Platform, a large-scale, widely adopted conversational...Work experience placementFlexible hours
airbnb, Inc.
San Francisco, CA4 days ago $300 per month
...performing team that believes in each other, come build with us at Crusoe.About This Role:We are seeking a Staff Hardware Systems Engineer to strengthen Crusoe’s Hardware Systems Engineering team and close critical skill gaps in debugging, validation, performance evaluation...Temporary work$110k - $140k
...50 million from some of the world’s best investors, from Andreessen Horowitz to Blackrock and Fidelity, and employs a team of 450 engineers and entrepreneurs. Astranis designs, builds, and operates its satellites out of its 153,000 sq. ft. headquarters in Northern California...Permanent employmentFull timeFlexible hours$211.7k - $302.4k
...Apple TV, and game consoles. Quality at this scale isn't a checkbox — it's a competitive advantage.We're looking for an Automation Engineering Managerto lead the team responsible for building and operating Tubi's multi-platform test automation infrastructure. You will own...Full timeTemporary workWork at officeLocal areaImmediate startFlexible hours2 days per week$90.2k - $135.4k
...professionally in a dynamic, global environment, surrounded by forward-thinking peers.We are seeking a highly motivated Automation Engineer to join our Enterprise Applications team. This role will focus on designing, developing,deploying and supporting automation/...Full time$215k - $260k
...team that believes in each other, come build with us at Crusoe.About This Role:We are seeking a Hardware Production / Sustaining Engineer to strengthen Crusoe’s Hardware Systems Engineering team and close critical skill gaps in debugging, validation, and production support...- ...candidates in the listed location(s) are encouraged for this role, candidates in other locations will be considered.The Databricks Field Engineering team activates and accelerates the value our customers get from their data and AI. Major media agencies, ad tech, and Data/...Worldwide
$42 - $65 per hour
Job TitleField Service Engineer - Medical Imaging (Northwest)Job DescriptionField Service Engineer - Medical Imaging (Northwest)You will be responsible for customer relationship management through the effective use of technical knowledge to install, troubleshoot, service...Full timeWork at officeImmediate startRemote workHome officeWork visaRelocation packageNight shift3 days per week$120k - $175k
...50 million from some of the world's best investors, from Andreessen Horowitz to Blackrock and Fidelity, and employs a team of 450 engineers and entrepreneurs. Astranis designs, builds, and operates its satellites out of its 153,000 sq. ft. headquarters in Northern California...Permanent employmentFull timeContract workFlexible hours$110k - $150k
The Opportunity:Tetra Tech is adding an Intermediate Civil Engineer to our Power Division team in Tampa, Florida (hybrid). Why Tetra Tech:At Tetra Tech, we are Leading with Science to solve the world’s most complex challenges. Our industry-leading experts in engineering...For contractorsWork experience placementWork at officeWorldwideFlexible hours- .... And that’s where you come in.DescriptionHitachi Rail is looking for an enthusiastic self-motivated Wayside and On-Board Service Engineer who thrives in a fast-paced environment. The successful candidate is comfortable performing a wide range of tasks from administrative...Work at officeLocal area
$107k - $150k
At Ouster, we build sensors and tools for engineers, roboticists, and researchers, so they can make the world safer and more efficient. We've transformed LIDAR from an analog device with thousands of components to an elegant digital device powered by one chip-scale laser...Work experience placementLocal areaFlexible hours$30 per hour
THE ROLE We are seeking a Mechanical Engineering Intern to join Heirloom’s Mechanical Team for the upcoming Fall/Water for a 10-12 week internship. In this role, you will support the design, build, and deployment of next-generation carbon removal systems. This is an opportunity...Hourly payFull timeInternshipRelocation package$170k - $250k
...B lifetime deliveries. We’re focused on how to do the next 10B even better.About the RoleWe are seeking a Senior/Staff Electrical Engineer to join our multidisciplinary team, with a focus on developing production-grade electrical systems for consumer and enterprise hardware...Hourly payContract workWork at officeLocal areaRemote workFlexible hours$130k - $160k
About Us:BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing...Full timeFlexible hours- ...50 million from some of the world’s best investors, from Andreessen Horowitz to Blackrock and Fidelity, and employs a team of 450 engineers and entrepreneurs. Astranis designs, builds, and operates its satellites out of its 153,000 sq. ft. headquarters in Northern California...Permanent employmentFlexible hours
- ...50 million from some of the world’s best investors, from Andreessen Horowitz to Blackrock and Fidelity, and employs a team of 450 engineers and entrepreneurs. Astranis designs, builds, and operates its satellites out of its 153,000 sq. ft. headquarters in Northern California...Permanent employmentFlexible hours
- Analyzing computer hardware problems, rectifying them, and replacing parts when necessary—acting as the middleman between user and manufacturer when equipment must be sent for repair—installing software, demonstrating its usage, and troubleshooting when users face problems...
Mainstreet Technologies Inc
San Francisco, CA2 days ago $162.59k
...Position Summary Under direction, perform varied professional and electrical engineering work at an advanced level of difficulty in the field and office. Perform assessments of and prepare written reports documenting the existing electrical systems and loads at existing...Full timeContract workFor contractorsWork at officeGolden Gate Bridge, Highway & Transportation District
San Francisco, CA12 days ago
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