Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required. * Understanding of programming and relational database concepts is required. Required ...
66 Katalyst System Validation Engineer Jobs Hiring Near You
Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required. * Understanding of programming and relational database concepts is required. Required ...
Computer System Validation Engineer
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
Computer System Validation Engineer
Tustin, CA · On-site
$82K - $104K/yr
The Computer System Validation Engineer is responsible for providing technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software that ...
SerDes System Validation Engineer
Austin, TX · On-site
$140 - $190/hr
We have an opportunity for a forward‑thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
SerDes System Validation Engineer
Austin, TX · On-site
$140 - $190/hr
We have an opportunity for a forward‑thinking and especially hardworking system validation engineer with strong background in high speed serial links. As a member of our dynamic team, you will have ...
CSV Engineer
Redwood City, CA · On-site
Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... CSV Engineer • Ensuring compliance with validation and regulatory standards Qualifications
CSV Engineer
Redwood City, CA · On-site
Katalyst CRO is looking for an experienced and well-rounded CSV (Computer System Validation ... CSV Engineer • Ensuring compliance with validation and regulatory standards Qualifications
Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
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Senior System Validation Engineer
Johns Creek, GA · Hybrid
$96K - $132K/yr
Senior System Validation Engineer This exciting role will be responsible for validating high-speed memory buffer semiconductor products, developing automation scripts, and ensuring system compliance ...
Embedded System Validation Engineer Job Location: Redmond, WA (Onsite) Job Type: Full Time Key Responsibilities: * Convert product and firmware requirements into structured test plans, validation ...
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Embedded System Validation Engineer Job Location: Redmond, WA (Onsite) Job Type: Full Time Key Responsibilities: * Convert product and firmware requirements into structured test plans, validation ...
Katalyst Jobs Information
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Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
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Katalyst is a forward-thinking company that has established itself as a leader in its industry, known for its commitment to innovation and customer satisfaction. The company's work environment is characterized by a collaborative and dynamic atmosphere, where employees are encouraged to share ideas and work together to drive progress. Joining Katalyst offers opportunities for professional growth and development, as well as the chance to contribute to meaningful projects that can have a lasting impact.
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Full-time
Re-posted 16 days ago
Job description
We are looking for a Labware LIMS CSV engineer with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.
Responsibilities
Required Experience / Skills:
Responsibilities
- Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
- Develop Validation testing strategy in accordance with Gilead's policy and procedures
- Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
- Assist with understanding the business requirements, analyze and suggest technical solution for LIMS projects
- Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
- Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
- Qualification protocols execution and final report view and approval for LIMS projects
- Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
- Learn and become proficient the EDMS (Electronic Data Management System), for
- Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Forms
- User Manuals / User Guides / User References / Quick Reference Guides and Training Material
- Training Plans
- Reference Documents
- Specifications
- Reports
- Work independently but recognize the need to consult stake holders and keep them informed of progress.
Required Experience / Skills:
- Minimum of 3-5 years of experience working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
- Advanced knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.
- Ability to master technical content through interaction with subject matter experts.
- Effective communication and interpersonal skills.
- Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
- Understanding of programming and relational database concepts is required.
- BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.
About Netpace
Sourced by ZipRecruiter
Netpace is a reputable company in the Information Technology and Services industry, headquartered in San Ramon, California, in the United States. The company specializes in providing digital transformation solutions by leveraging cutting-edge technologies. It offers a wide array of services, including Software Development, IT Consulting, Cloud Services, Infrastructure Management, and Digital Marketing. Ever since its launch, Netpace has been driven by a mission to use technology as a medium to shape future businesses and make a significant impact.
Company size
51 - 200 Employees
Headquarters location
San Ramon, CA, US
Year founded
1996