validation & compliance engineer Jobs

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Validation Engineer III

Katalyst Healthcares and Lifesciences

Plainsboro Township, New Jersey, USA

Full-time

Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment Qualification Process Qualification The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with

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

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

Validation Engineer

Katalyst Healthcares and Lifesciences

Los Angeles, California, USA

Full-time

Responsibilities: Conceives, plans and executes manufacturing process validations plans and studies. dhere to the Change Control and Design Control requirements. To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's. Being the lead on the writing and execution of IQ/OQ/PQ protocols. RCH/PCH - Routing in MAP Agile & follow up till release. Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD). Preparing protocol & executing Test Meth

Validation Engineer

Katalyst Healthcares and Lifesciences

Princeton, New Jersey, USA

Full-time

Roles & Responsibilities: Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements and industry standards. Create detailed validation documentation including plans, reports, and scripts. Conduct risk assessments and impact analyses related to computer systems. Coordinate and supervise testing activities. Collaborate with cross-functional teams to maintain and improve system validation processes. Monitor and report on validation project

Validation Engineer

Katalyst Healthcares and Lifesciences

Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to

Senior Staff System Validation Engineer

Marvell Semiconductor Inc.

Santa Clara, California, USA

Full-time

About Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier architectures, our innovative technology is enabling new possibilities. At Marvell, you can affect the arc of individual lives, lift the trajectory of entire industries, and fuel the transformative potential of tomorrow. For those looking to make their mark on purposeful and enduring innovation, above and be

Senior Principal Validation Engineer - SERDES

Marvell Semiconductor Inc.

Santa Clara, California, USA

Full-time

About Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier architectures, our innovative technology is enabling new possibilities. At Marvell, you can affect the arc of individual lives, lift the trajectory of entire industries, and fuel the transformative potential of tomorrow. For those looking to make their mark on purposeful and enduring innovation, above and be

Vehicle Hardware - Sr. Mechatronics Test & Validation Engineer

Rivian

Irvine, California, USA

Full-time

About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it

Computer System Validation

Sharpedge Solutions

Raritan, New Jersey, USA

Full-time

Role - CSV Engineer Location - Raritan, NJ(Hybrid) Job Details: 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 ServiceNOW, 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

Database and Capture Engineer

Vaco by Highspring

Menlo Park, California, USA

Contract

We are seeking an experienced engineer to lead the development of a centralized image capture and data infrastructure supporting next-gen camera validation. This role blends hands-on camera work with backend data engineering to ensure image data is organized, accessible, and scalable across teams. What Youll Do Build and manage image capture workflows in lab environments. Develop infrastructure for automated image upload, tagging, and indexing. Define and enforce metadata standards for consisten

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

Electrical Test Engineer

Axiom Global Technologies, Inc.

Palo Alto, California, USA

Third Party, Contract

Role: Electrical Test Engineer Location: Palo Alto, CA (Onsite) Duration: 12+ month Job Description: In this role, the electrical engineer needs to support test and characterization of electronic hardware design Key Responsibilities: Experience in end-to-end hardware development life cycle - requirement analysis, architecture design / analysis, implementation, testing, validation, compliance certification to General Availability (GA)Experience with Power PC/ARM/NXP/Intel processors, Microcontrol

Application Engineer - Liquid Adhesives

3M Company

Maplewood, Minnesota, USA

Full-time

Job Description: Application Engineer - Liquid Adhesives Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a wide variety of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers. This po

EMC Test Engineer

Yoh - A Day & Zimmerman Company

Fremont, California, USA

Full-time

EMC Test Engineer We are seeking an experienced EMC Test Engineer to support product development through electromagnetic compatibility (EMC) testing and compliance. This role will focus on executing tests at the board, sub-assembly, and system level while supporting debugging and process improvement efforts across cross-functional teams. Scope: Execute compliance EMC testing on PCBAs, sub-assemblies, and full systems, including radiated/conducted emissions and immunity Perform ESD and transient

Systems Engineer - IT Manufacturing Infrastructure

Canopy One Solutions Inc

Indianapolis, Indiana, USA

Contract, Third Party

Position: Workstation Analyst - IT Manufacturing Infrastructure Location: Indianapolis, IN (onsite) Duration: 6 months The Analyst IT Mfg. provides support for Manufacturing & Quality, process and building automation equipment installation, end user support, and special project custom applications. Key Responsibilities: Perform technical requirements analysis of workstation infrastructure design Coordinate with vendors regarding requirements, operating system requirements, additional hardware

Senior Electrical Engineer - Embedded Systems & Circuit Design

Dexian DISYS

Bradenton, Florida, USA

Full-time

Job Title: Senior Electrical Engineer - Embedded Systems & Circuit Design Location: Bradenton, FL Job Type: Full-Time | Engineering Role Overview We are seeking a Senior Electrical Engineer with extensive experience in analog/digital circuit design and embedded system development. This role involves leading complex design projects, ensuring regulatory compliance, and mentoring engineering team members. The ideal candidate will have a strong foundation in high-speed digital systems, embedded ar

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

Hardware Engineer - mTIB Support (OCTA/NFTA)

Alpha Silicon

Columbia, Maryland, USA

Contract, Third Party

Title: Hardware Engineer - mTIB Support (OCTA/NFTA) Location: Columbia MD Terms: Contract Job Description Justification: Required to assist the mTIB developer with integration and hardware validation support for transit systems at OCTA and NFTA Job Responsibilities: Provide hardware integration, validation, and troubleshooting support for internally developed hardware boards to be deployed transit sites. Collaborate closely with the product development team to ensure hardware and software co

Senior Hardware Design Engineer Digital Systems PCB

Paul May & Associates

Saint Charles, Missouri, USA

Full-time

Job Title: Senior Hardware Design Engineer Digital Systems PCB Location: St. Charles, MO (Must be local Hybrid role) Salary: $120K $140K base, depending on experience Employment Type: Full-Time | No relocation or sponsorship Overview: We're hiring a Hardware Design Engineer with strong digital design experience and some analog knowledge. You'll design advanced systems using FPGAs and CPUs, create PCB layouts, and work with power and signal systems. Projects often involve Power over Ethernet (