Validation Engineer
Irvine, CA · On-site
The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous ...
60 Katalyst Validation Engineer Jobs Hiring in CA
Validation Engineer
Irvine, CA · On-site
The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous ...
Develop and execute validation plans and reports. * Analyze data and troubleshoot process deviations. * Ensure compliance with FDA regulations and ISO standards. * Collaborate with Engineering and ...
Develop and execute validation plans and reports. * Analyze data and troubleshoot process deviations. * Ensure compliance with FDA regulations and ISO standards. * Collaborate with Engineering and ...
Validation Engineer
San Francisco, CA · On-site
Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered. * Include Must Have: * Validation ...
Validation Engineer
San Francisco, CA · On-site
Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered. * Include Must Have: * Validation ...
Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered. Include Must Have: * Validation ...
Bachelor's degree in Engineering, Science, Life Sciences, or related technical discipline preferred. Equivalent hands-on validation experience can be considered. Include Must Have: * Validation ...
Support of creating and maintaining GxP (GMP, GCP, GLP) quality and Perform GxP and 21 CFR part 11 assessments and develop a validation plan. * Develop functional risk strategy and perform functional ...
Support of creating and maintaining GxP (GMP, GCP, GLP) quality and Perform GxP and 21 CFR part 11 assessments and develop a validation plan. * Develop functional risk strategy and perform functional ...
Validation Engineer
Vacaville, CA · On-site
Minimum of two years' experience in Validation or equipment qualification is desired. * Ability to make sound decisions about scheduling and managing priorities. * Flexibility in problem-solving ...
Validation Engineer
Vacaville, CA · On-site
Minimum of two years' experience in Validation or equipment qualification is desired. * Ability to make sound decisions about scheduling and managing priorities. * Flexibility in problem-solving ...
Validation Engineer
Vacaville, CA · On-site
Minimum of two years' experience in Validation or equipment qualification is desired. * Ability to make sound decisions about scheduling and managing priorities. * Flexibility in problem-solving ...
Validation Engineer
Vacaville, CA · On-site
Minimum of two years' experience in Validation or equipment qualification is desired. * Ability to make sound decisions about scheduling and managing priorities. * Flexibility in problem-solving ...
Test Method Validation
Santa Clarita, CA · On-site
We are seeking an Engineer to support product development and design verification activities for ... Review and support Test Method Validation activities and test fixture design qualification.
Test Method Validation
Santa Clarita, CA · On-site
We are seeking an Engineer to support product development and design verification activities for ... Review and support Test Method Validation activities and test fixture design qualification.
We are seeking an experienced Validation & Verification (V&V) SME with 8-12+ years of experience in the Medical Device industry. * The ideal candidate will independently lead end-to-end validation ...
We are seeking an experienced Validation & Verification (V&V) SME with 8-12+ years of experience in the Medical Device industry. * The ideal candidate will independently lead end-to-end validation ...
Provide validation and testing services to ensure system integrity, data accuracy, and regulatory compliance for Poseida integration initiatives. Support validation activities across QMS migration ...
Provide validation and testing services to ensure system integrity, data accuracy, and regulatory compliance for Poseida integration initiatives. Support validation activities across QMS migration ...
CSV Engineer
San Francisco, CA · On-site
Develop and implement validation strategies for computer systems and software applications ... Bachelor's degree in Computer Science, Engineering, or a related field. * Minimum of 2-5 years of ...
CSV Engineer
San Francisco, CA · On-site
Develop and implement validation strategies for computer systems and software applications ... Bachelor's degree in Computer Science, Engineering, or a related field. * Minimum of 2-5 years of ...
CSV Engineer
San Francisco, CA · On-site
Develop and implement validation strategies for computer systems and software applications ... Bachelor's degree in Computer Science, Engineering, or a related field. * Minimum of 2-5 years of ...
CSV Engineer
San Francisco, CA · On-site
Develop and implement validation strategies for computer systems and software applications ... Bachelor's degree in Computer Science, Engineering, or a related field. * Minimum of 2-5 years of ...
CQV Engineer
San Francisco, CA · On-site
Ensure systems are ready for handover to validation/operations. Requirements: * 4-7 years' experience within CQV / Process Engineering in GMP environments. * Hands-on experience with system ownership ...
CQV Engineer
San Francisco, CA · On-site
Ensure systems are ready for handover to validation/operations. Requirements: * 4-7 years' experience within CQV / Process Engineering in GMP environments. * Hands-on experience with system ownership ...
Validation Specialist
Los Angeles, CA · On-site
Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related ... Validation protocols and reportsRisk assessments (FMEA, impact assessments)SOPs, deviation ...
Validation Specialist
Los Angeles, CA · On-site
Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related ... Validation protocols and reportsRisk assessments (FMEA, impact assessments)SOPs, deviation ...
Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures ... Implement and maintain standardized programming templates, macros, and tools to ensure consistency ...
Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures ... Implement and maintain standardized programming templates, macros, and tools to ensure consistency ...
Clinical SAS Programmer
Santa Clara, CA · On-site
Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures ... Implement and maintain standardized programming templates, macros, and tools to ensure consistency ...
Clinical SAS Programmer
Santa Clara, CA · On-site
Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures ... Implement and maintain standardized programming templates, macros, and tools to ensure consistency ...
Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I - IV clinical trials, integrated clinical summaries, responses to ...
Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I - IV clinical trials, integrated clinical summaries, responses to ...
R&D Engineer
San Jose, CA · On-site
We are seeking an innovative and detail-oriented R&D Engineer to support the research, design, development, and validation of new products and technologies. The ideal candidate will collaborate with ...
R&D Engineer
San Jose, CA · On-site
We are seeking an innovative and detail-oriented R&D Engineer to support the research, design, development, and validation of new products and technologies. The ideal candidate will collaborate with ...
Lead Quality Engineer
Irvine, CA · On-site
$76K - $98K/yr
We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality ... The role will lead quality improvement initiatives, validation activities, risk management, CAPA ...
Lead Quality Engineer
Irvine, CA · On-site
$76K - $98K/yr
We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality ... The role will lead quality improvement initiatives, validation activities, risk management, CAPA ...
Quality Engineer
Lake Forest, CA · On-site
$75K - $98K/yr
The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA ...
Quality Engineer
Lake Forest, CA · On-site
$75K - $98K/yr
The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
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.
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.
What makes Katalyst an attractive place to work?
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.
What are the most popular jobs at Katalyst in California?
Job description
Job Summary:
The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous Improvement (CIP) initiatives, supporting process validation, and ensuring compliance with applicable regulatory standards. The engineer will collaborate with internal teams and external suppliers to improve product performance, reduce costs, and ensure robust validation of systems and processes, including those related to product electrical design and functionality.
Roles & Responsibilities:- Lead Continuous Improvement (CIP) projects in collaboration with cross-functional internal teams and external suppliers.
- Perform CIP calculations, including supplier quotation evaluations and cost-benefit analysis.
- Develop and manage project budgets covering feasibility studies, capital equipment, validation costs, DVT samples, and related testing requirements (e.g., bioburden).
- Create detailed project plans using Microsoft Project and prepare presentation materials using PowerPoint.
- Demonstrate understanding of product electrical design, system architecture, and functional performance.
- Lead design changes, component substitutions, and supplier transitions to achieve cost savings and improved performance (Type II savings).
- Develop strategies to meet CIP targets and drive continuous improvement initiatives.
- Conduct engineering testing, develop test protocols, prepare test reports, and participate in design reviews.
- Oversee project execution including timelines, dependencies, and task coordination.
- Identify appropriate electrical test methods and collaborate with R&D teams to align requirements.
- Review engineering requirements, support process validation activities, and finalize validation documentation (e.g., RR forms, validation reports).
- Execute change control processes and supplier change requests.
- Communicate technical issues, risks, and opportunities to management.
- Ensure compliance with Health, Safety, Environmental, and regulatory requirements.
- Maintain adherence to federal, state, local, and company procedures.
- Provide technical guidance or supervision to junior engineers or technicians as needed.
- Bachelor's degree in Electrical Engineering, Mechanical Engineering, Software Engineering, or related Engineering discipline.
- 3–5 years of relevant experience in validation engineering, product engineering, or manufacturing engineering within a regulated industry.
- Experience in medical device or similarly regulated environments preferred.
- Strong understanding of validation processes, process engineering, and engineering documentation.
- Experience with Continuous Improvement (CIP), supplier coordination, and project execution is highly desirable.
- Familiarity with product design, electrical systems, and engineering test methods is preferred.
- Proficiency in Microsoft Project and PowerPoint is an added advantage.
- Strong knowledge of regulatory requirements and quality systems in a manufacturing environment.