Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to Requirement ...
72 Katalyst Validation Engineer Jobs Hiring Near You
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for ... Creation and review of validation deliverables including but not limited to Requirement ...
* 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 ...
* 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
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
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
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 ...
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 ...
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 ...
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 ...
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
Irvine, CA · On-site
Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal ...
Validation Engineer
Irvine, CA · On-site
Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal ...
* 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 ...
* 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
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
Waltham, MA · On-site
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
Waltham, MA · On-site
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
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
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
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 ...
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 ...
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
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
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
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 ...
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 other companies are hiring for Validation Engineer jobs?
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Validation Engineer/CSV Engineer
Walnut Creek, CA • On-site
Katalyst Healthcares & Life Sciences
• Scientific Research and Development Services • 51 - 200 employees51 - 200 employees
Contractor
Re-posted 26 days ago
Job description
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Responsibilities:
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
- Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
- Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
- Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
- Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
- Traceability Matrix.
- Periodic Reviews.
- System Retirement/Decommissioning.
- Execution of Dry/Test protocol run.
- Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
- Perform System Retirement/Decommissioning of systems not in business.
- Work closely with software development and IT teams to establish best practices for quality and compliance.
- Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
- Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
Requirements:
- A Minimum bachelor's degree in engineering, Science or related technical field.
- Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
- Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Experience with non-product software validation, including tools for development, testing, and maintenance.
- Good knowledge and experience of CSV activities but not limited to.
- GxP and 21 CFR Part 11 applicability/criticality assessment.
- Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
- Execution of Dry/Test protocols.
- Conduct Periodic Reviews of systems.
- Perform System Retirement of systems that are not in business.
- Understanding of Medical Device Quality and Compliance.
- Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
- Working experience in Product Lifecycle Management (PLM) tool.
- Sound knowledge of computer system development lifecycles.
- Knowledge of JIRA, JAMA software and test automation is a plus.
Additional Information
All your information will be kept confidential according to EEO guidelines.
About Katalyst Healthcares & Life Sciences
Sourced by ZipRecruiter
Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US