Process Validation Engineer Jobs

1 - 20 of 279 Jobs

Sr Process Validation EngineerJob Title - Sr Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Franklin Lakes, New Jersey, USA

Full-time

Responsibilities: Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Colorado, USA

Full-time

Job Description: Process Validation Engineer with 5+ years of engineering experience. This role includes an in-depth training program, where the consultant will be paired with a team member to review training materials and receive hands-on floor training related to process validation and supplier quality activities. The engineer will work cross-functionally to assess manufacturing and supplier quality processes, identify improvement opportunities, and implement effective solutions. Strong c

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Colorado Springs, Colorado, USA

Full-time

Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file. Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers. Strong Communicator to manage stakeholders and provide b

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: Provide technical support and routine process monitoring for commercial products manufactured at CMOs. Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team. Reviews manufacturing processes, deviations, and/or development and production data. Reviews manufacturing batch records, protocols, and control strategies. Provide technical support and data analysis for investigations and deviation resolution. Recommen

Sr Process Validation EngineerJob Title - Sr Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Lead process validation projects of broad scope. Collaborate with clients, Validation, and cross-functional team members to coordinate projects, resolve issues, and meet aggressive timelines. Represent Validation in customer interactions and communicate customer requirements to the broader Validation team as needed. Oversee execution of process validation (PPQ) protocols on the production floor on varying shifts as needed to ensure that protocol requirements are satisfi

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Swiftwater, Pennsylvania, USA

Full-time

Roles & Responsibilities: Bachelor's degree in science or engineering (MS accepted, PhD is overqualified). Minimum 2+ years in Process Validation within the biotech/pharma industry. Writing and executing process validation documents. Strong Process Performance Qualification (PPQ) experience. Hands-on experience collecting process samples. Must have on-the-floor manufacturing experience. Familiarity with GMP best practices. Proficient in MS Office (Word, Excel, PowerPoint). Strong w

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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East Windsor, New Jersey, USA

Full-time

Responsibilities: Previous experience as a validation engineer in an aseptic pharmaceutical fill/finish environment. Prior experience executing validation protocols on a pharmaceutical fill/finish line. Specific line components include. Lyophilizers. Depyrogenation tunnels. Autocalves. Previous experience with the project management requirements of validation project in a GMP environment. Requirements: Managing validation schedule. Communication of delays and changes to timelines. Coor

Sr. Process Validation EngineerJob Title - Sr. Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Minimum 7 years of CQV experience in a parenteral fill/finish environment. Lead process validation projects of broad scope. Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required. Provide technical support to Manufacturing - troubleshooting and resolving process related issues. Participate in investigations and provide documentation

Principal Process Controls & Validation EngineerJob Title - Principal Process Controls & Validation Engineer

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Rensselaer, New York, USA

Full-time

Regeneron is currently looking for a Principal/ Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes f

Off highway mobile equipment Verification and Validation EngineerJob Title - Off highway mobile equipment Verification and Validation Engineer

SGS ConsultingCompany Name - SGS Consulting

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Coffeyville, Kansas, USA

Contract

Job Title: Product Verification and Validation Engineer Location: Coffeyville, KS- 67337 Job Duration : 01 Years (possible extension) Job Type: Contract Work Hours: 7:30 am to 4.00 pm Shift: 1st Shift Start time is somewhat flexible Pay Rate: $55-58/Hour on w2 The final pay rate will be determined based on factors such as your relevant skills, education, experience, and the benefits package you select Benefits: Employees are eligible to participate in our comprehensive benefits plan, which inclu

Memory Validation EngineerJob Title - Memory Validation Engineer

Cynet SystemsCompany Name - Cynet Systems

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Austin, Texas, USA

Contract

Job Description: Responsibilities: Execute electrical, functional, & system tests of DDR5 and LPDDR5x memory sub-system test plans as part of a post silicon platform engineering team using hardware and software validation tools, oscilloscopes, and logic analyzers. Develop technical test plans and tools to support platform level silicon bring-up and the validation execution of DDR5 and LPDDR5x memory subsystems. Analyze & debug electrical and functional test data to drive into production SOC a

Hardware Validation Engineer- Irvine CAJob Title - Hardware Validation Engineer- Irvine CA

Belcan Services Group, Limited PartnershipCompany Name - Belcan Services Group, Limited Partnership

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Irvine, California, USA

Contract

Job Title: Hardware Validation Engineer Location: 14600 Myford Road, Irvine CA 92606 Duration: 12 months Pay Rate: $55/hr. Job Description: Responsibilities: Validation Planning & Criteria Development: Develop and manage comprehensive validation plans for mechatronic systems and sub-systems, ensuring all design and performance requirements are met.Establish testing criteria for accurate and reliable results, including sample size, statistical analysis, and attribute vs. variable testing.Test Pla

Sensing HW Validation Engineer (Test Engineer III)Job Title - Sensing HW Validation Engineer (Test Engineer III)

WinMax Systems CorporationCompany Name - WinMax Systems Corporation

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Cupertino, California, USA

Contract

Job Title: Sensing HW Validation Engineer (Test Engineer ) - 36081285 Job Duration: 12+ Months Job Location: Cupertino, CA - Fully Onsite Job Summary: The Sensing HW team develops groundbreaking sensors that are central to a variety of Client's platforms, including iPhones, iPads, Audio, Macs, the Home ecosystem, and accessories. You will play a key role in developing, characterizing, and validating sensor systems used in these platforms. The ideal candidate will have expertise in touch sensin

Platform Validation EngineerJob Title - Platform Validation Engineer

Horizontal TalentCompany Name - Horizontal Talent

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Contract

We are seeking a talented Platform Validation Engineer to join our dynamic team. This role offers a unique opportunity to work on cutting-edge technology in a hybrid work environment, contributing to the future of computing. ResponsibilitiesConduct hardware platform testing and pre/post-silicon validations to ensure optimal performance.Develop and implement system-level tests for SoC and peripherals, reporting progress and issues effectively.Engage in debugging and troubleshooting, particularly

Systems Engineer (Sys Integr, Ver & Validation)Job Title - Systems Engineer (Sys Integr, Ver & Validation)

Boeing CompanyCompany Name - Boeing Company

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Everett, Washington, USA

Full-time

Systems Engineer (Sys Integr, Ver & Validation) Company: The Boeing Company Refer to "Supplemental Information" for further clarification on the use of this job family. In locations where SPEEA representation applies, this job family will be covered by the terms of the collective bargaining agreement. Applicable and appropriate educational/certification credentials from an accredited institution and/or equivalent experience is required. Language Requirements: Not Applicable Education: Bachel

Validation Engineer (Firmware Testing) Position in Boise IDJob Title - Validation Engineer (Firmware Testing) Position in Boise ID

Vailexa Technology LLCCompany Name - Vailexa Technology LLC

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Boise, Idaho, USA

Contract

Position: Validation Engineer with Firmware Testing Location: Longmont, CO Duration: 12 monthsOverall All: 5+ years of experience required - candidates with a background in the semiconductor industry will be strongly preferred. Role Description: Review the Failures from Daily/weekly validation runs, First-levelFailure analysis: Assign the failures to the Actual Test developer or owner & Notify themFollow up on the further FA triage File the Firmware JIRAs & Test bugs JIRAs after the Triage, and

ATE Software Validation Engineer Medical DevicesJob Title - ATE Software Validation Engineer Medical Devices

Sureminds SolutionsCompany Name - Sureminds Solutions

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Skaneateles Falls, New York, USA

Third Party, Contract

Job Title: ATE Software Validation Engineer Medical Devices Location: Skaneateles Falls, NY (Onsite) Duration : Long-Term Interview Mode : Video Job Description : Automatic Test Equipment (ATE) Software Validation Engineer Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices.Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Key Responsibilities: Lead sof

Sr. Electrical Engineer, Power Electronics Test & ValidationJob Title - Sr. Electrical Engineer, Power Electronics Test & Validation

Tranzeal, Inc.Company Name - Tranzeal, Inc.

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Fremont, California, USA

Contract

Sr. Electrical Engineer Power Electronics Test & Validation We are seeking a skilled Sr. Electrical Engineer with expertise in power electronics design, testing, and validation to ensure high-performance, reliable, and compliant systems. Key Responsibilities:Design, review, and analyze power electronics topologies, schematics, PCB layouts, and converter simulations. Conduct verification and validation testing of power electronics systems, ensuring compliance with industry standards. Perform hand

Software Infrastructure Engineer (Redmond/ Seattle/ Bay area, silicon or firmware validation, C, C++, Python, software testing)Job Title - Software Infrastructure Engineer (Redmond/ Seattle/ Bay area, silicon or firmware validation, C, C++, Python, software testing)

FervorlyCompany Name - Fervorly

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Redmond, Washington, USA

Contract, Third Party

We are seeking a Software Infrastructure Engineer to join our End-to-End (E2E) System and Infrastructure team. In this pivotal role, you will be instrumental in building, scaling, and maintaining the essential laboratory software infrastructure that underpins our Firmware (FW), Software (SW), and Design Verification (DV) development, as well as system integration efforts. Your work will span both pre-silicon and post-silicon platforms, ensuring high confidence and efficiency in our silicon devel