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Validation Support Engineer

Katalyst Healthcares and Lifesciences

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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 56 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Huntington, Texas, USA

Full-time

Roles & Responsibilities: M.S. in Engineering or Biomedical Engineering 1+ year of professional experience in a Medical Device Manufacturing Environment Lead, execute, document & manage the validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for Ophtalmic medical devices Design, develop, validate and implement manufacturing processes to build opthalmic medical devices for cataract and vitroreti
Posted 60+ days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi
Posted 60+ days ago | Updated 9 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

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. V
Posted 60+ days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Norwood, Massachusetts, USA

Full-time

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also
Posted 6 days ago | Updated 9 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 16 days ago | Updated 9 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

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Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 60+ days ago | Updated 9 hours ago

Commissioning and Qualification Engineer

Katalyst Healthcares and Lifesciences

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Raleigh, North Carolina, USA

Full-time

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro
Posted 60+ days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently. Support onsite and offsite activities, such as: FATs, SATs, IOQ
Posted 60+ days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan
Posted 6 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Nashville, Tennessee, USA

Full-time

Responsibilities: Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes: These confirm proper functionality and adherence to operational specifications. Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products. Conduct revalidation of equipment and processes when changes occur, such as: ssess risks related to equipment, processes, and production areas that could impact product qua
Posted 60+ days ago | Updated 9 hours 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 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Richmond, Virginia, USA

Full-time

Responsibilities: Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications. Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging. Regularly revali
Posted 60+ days ago | Updated 9 hours ago

Plastics Process Engineer

Jobot

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Tampa, Florida, USA

Full-time

Drive Process Excellence in Class I- Medical Device Manufacturing This Jobot Job is hosted by: Ryan Weingardt Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $95,000 per year A bit about us: We are a Florida-based injection molder specializing in high-precision, low-to-mid volume production for the medical device and life sciences industries. With ISO Class 7 and 8 cleanroom capabilities and a track record of producing Class I, II
Posted 3 days ago | Updated 1 hour ago

Lead Engineer

Katalyst Healthcares and Lifesciences

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Sandy, Utah, USA

Full-time

Job Description: Onsite Engineer plans, leads, reviews and front-ends Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development. Responsibilities: Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools. Demonstrates good project management, contributes on projects as the R&D member, carrying
Posted 9 hours ago

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

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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 8 days ago | Updated 9 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 6 days ago | Updated 9 hours ago

Validation Engineer - Virginia (Multiple Openings)

Novo Nordisk Inc

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Petersburg, Virginia, USA

Full-time

About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The
Posted 13 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 9 hours ago

Engineer Principal

ACL Digital

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New Albany, Ohio, USA

Full-time

Ideal candidate: 10 YOE. Onsite AOH - Monday - Friday - Standard 8-5 Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month. Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to
Posted 16 days ago | Updated 9 hours ago