Validation Engineer
Cambridge, MA · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
64 Katalyst Validation Engineer Jobs Hiring Near You
Validation Engineer
Cambridge, MA · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
Requirements: * Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill ...
Validation Engineer
Minneapolis, MN · On-site
We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated ...
Validation Engineer
Minneapolis, MN · On-site
We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated ...
Validation Engineer
Tucson, AZ · On-site
* We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and ...
Validation Engineer
Tucson, AZ · On-site
* We are seeking a proactive Validation Engineer with 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably. FDA) to ensure compliance and ...
Validation Engineer
Manchester, NH · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
Validation Engineer
Manchester, NH · On-site
We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands-on expertise in IQ/OQ/PQ ...
Validation Engineer
Bothell, WA · On-site
Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in ...
Validation Engineer
Bothell, WA · On-site
Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in ...
Validation Engineer
Vail, AZ · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Validation Engineer
Vail, AZ · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment. * This role requires ...
We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment. * This role requires ...
Validation Engineer
Boston, MA · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Boston, MA · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Springfield, MA · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Validation Engineer
Springfield, MA · On-site
* Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands ...
Validation Engineer
Vail, AZ · On-site
We are seeking a proactive Validation Engineer with in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity.
Validation Engineer
Vail, AZ · On-site
We are seeking a proactive Validation Engineer with in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA) to ensure compliance and drive operational integrity.
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
Validation Engineer
Round Lake, IL · On-site
We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. * The role involves planning and executing V&V ...
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 ...
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 ...
Validation Engineer
Salt Lake City, UT · On-site
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Key Requirements: * bachelor ...
Validation Engineer
Salt Lake City, UT · On-site
We are looking for an experienced Validation Engineer with a strong background in the Medical Device industry to support validation and project execution activities. Key Requirements: * bachelor ...
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
Houston, TX · On-site
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: * Develop and execute IQ, OQ, PQ ...
Validation Engineer
Houston, TX · On-site
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: * Develop and execute IQ, OQ, PQ ...
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 ...
Validation Engineer
Boxborough, MA · On-site
Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience * Test Engineer that can help qualify Automated Functional Testers. * Would be responsible ...
Validation Engineer
Boxborough, MA · On-site
Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience * Test Engineer that can help qualify Automated Functional Testers. * Would be responsible ...
Validation Engineer
Portsmouth, NH · On-site
Bachelor's Degree (Computer Science / Software Engineering). * Advanced - 5-10 years. * Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation. * Strong ...
Validation Engineer
Portsmouth, NH · On-site
Bachelor's Degree (Computer Science / Software Engineering). * Advanced - 5-10 years. * Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation. * Strong ...
Validation Engineer
Enola, PA · 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
Enola, PA · 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 ...
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.
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Job description
Roles & Responsibilities:
- We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
- Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.
- A solid working knowledge of regulatory frameworks is essential - specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 - along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.
- Experience with PFMEA and change control impact assessments is also expected.
- On the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
- Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.
- Strong technical writing skills are a must - this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.
- Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day-to-day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.