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Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 3 days ago | Updated 1 hour ago

Reliability Engineer

Cushman & Wakefield

•

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary As a key member of the Reliability Engineering team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role will drive the implementation of maintenance and reliability best practices, focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead
Posted 22 days ago | Updated 1 hour ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

•

Walnut Creek, California, USA

Full-time

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 applicabi
Posted 4 days ago | Updated 1 hour ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service NOW, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 20 days ago | Updated 1 hour ago

SUD Validation Engineer

Thermo Fisher Scientific

•

Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 34 days ago | Updated 1 hour ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

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 applicabi
Posted 17 days ago | Updated 1 hour ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

•

North Chicago, Illinois, USA

Full-time

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 applicabi
Posted 18 days ago | Updated 1 hour ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 60+ days ago | Updated 1 hour ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Pennsylvania, USA

Full-time

Responsibilities: The areas of focus will be on Cell Therapy and Temperature mapping. Preparation and execution of Qualification Protocols and Reports. Design Qualification (DQ). Installation Qualification (IQ). Operational Qualification (OQ). Performance Qualification (PQ). Review and/or authoring of supporting validation documentation. User Requirements Specifications (URS). Risk Assessments (e.g., SIA). Commissioning Test Report. Thermal mapping strategy definition and execution. Execution of
Posted 1 hour ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

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 applicabil
Posted 22 days ago | Updated 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Libertyville, Illinois, USA

Full-time

Responsibilities: Lead validation efforts for injection molding machines, auxiliary equipment (e.g., dryers, chillers, robots), and integrated automation systems. Develop and execute validation protocols (SAT, FAT, IQ, OQ, PQ) for molding and downstream equipment. Support the qualification of new production lines involving injection-molded components. Perform process characterization, capability studies, and stability testing for moulded parts. Collaborate with tooling, manufacturing, and q
Posted 9 days ago | Updated 1 hour ago

Java AWS with GKP & GAP

Donato Technologies Inc

•

New York, New York, USA

Contract

Java AWS with GKP & GAP New York, NY 45 miles 8+ Yrs. of exp Primary Skills: Java + Web services - Gkp gap, kafka strong, Spring boot kafka strong, Spring boot Java FSD with AWS Primary Skills: Java + Web services - Gkp gap, kafka strong, Spring bootAn FSD/FSPE has an end to end product mindset - design, implementation, testing and deployment, and adds an additional skill (s) on top of traditional front/back-end developer role Design and developer application using Core Java Design and deve
Easy Apply
Posted 9 days ago | Updated 5 days ago

CQV Engineers Needed - Spring House, PA_Onsite job

Stellent IT LLC

•

Spring House, Pennsylvania, USA

Contract, Third Party

Hiring for - TITLE - CQV Engineers - Spring House, PA_Onsite job They are going to need 25-30 CQV Engineers to assist on this project. Initial 6 12-month project. The areas of focus will be on Cell Therapy and Temperature mapping Need - LINEKDIN match with updated resume, no FAKE people Multiple CQV Engineers needed to support a project in Spring House, PA. The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and lab
Easy Apply
Posted 3 days ago | Updated 1 day ago

Technical Business Analyst

TekLeaders, Inc

•

Jersey City, New Jersey, USA

Full-time, Part-time, Contract, Third Party

Title: Technical Business Analyst Location: Jersey City NJ and Columbus Ohio-Hybrid 3 days a week Required skills: Gather, document, and analyze business requirements and translate them into functional and technical specifications. Collaborate with product owners, business stakeholders, and engineering teams to ensure alignment of solutions with business goals. Work with QA teams to define test cases and ensure quality delivery through user acceptance testing (UAT). Perform gap analysis, imp
Easy Apply
Posted 11 days ago | Updated moments ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 1 hour ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 60+ days ago | Updated 1 hour ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG
Posted 17 days ago | Updated 1 hour ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 18 days ago | Updated 1 hour ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.
Posted 60+ days ago | Updated 1 hour ago

Senior DeltaV Automation Engineer

Katalyst Healthcares and Lifesciences

•

Muskegon, Michigan, USA

Full-time

Job Description: Are you a DeltaV expert with hands-on experience developing automation code within the DeltaV platform? Do you thrive in a collaborative environment and enjoy mentoring junior engineers? If so, we want to hear from you! Responsibilities: Develop automation code within DeltaV (Control Modules, Equipment Modules, Phases, Recipes). Identify, troubleshoot, and resolve software errors within the DeltaV system. Conduct Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),
Posted 60+ days ago | Updated 1 hour ago