process validation engineer Jobs

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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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Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu

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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Austin, Texas, USA

Full-time

Responsibilities: Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards. Actively participate in all phases of process qualification. Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyze data, and prepare reports. Lead all assigned qualification activities and make independent decisions related to thes

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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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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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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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

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

Sr. Cleaning Validation EngineerJob Title - Sr. Cleaning Validation Engineer

VetForce SolutionsCompany Name - VetForce Solutions

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Seattle, Washington, USA

Contract

Sr. Cleaning Validation Engineer Onsite in Seattle, WA 6 month contract to start with likely extensions Musts- 8+ years of experience in cleaning validation within GMP/CDMO environments Strong knowledge of cleaning processes, facility/utilities validation, and regulatory requirements Experience with computer system validation (CSV) preferred Demonstrated ability to write, review, and execute validation documentation

Validation EngineerJob Title - Validation Engineer

Source Code Technologies LLCCompany Name - Source Code Technologies LLC

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Sunnyvale, California, USA

Contract

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role Description: 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 sof

FPGA Validation Engineer (Vivado)Job Title - FPGA Validation Engineer (Vivado)

Mirafra IncCompany Name - Mirafra Inc

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San Jose, California, USA

Full-time

Develop and execute post silicon Validation and Characterization for clocking circuits on in some of the industry s largest and most complex SOCs (using Xilinx s FPGA design tools such as Vivado/ISE).Hands-on experience with lab equipment such as oscilloscopes, logic analyzers,Thermosteamer, Clock generators and other equipment.Expert knowledge and hands-on experience of the entire backend and adjacent flows, including synthesis, Floor-planning P&R, clocking, timing closure, power, and IO plann

Need - Computer Software Validation (CSV) EngineerJob Title - Need - Computer Software Validation (CSV) Engineer

ASCII Group LLCCompany Name - ASCII Group LLC

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Santa Clara, California, USA

Contract, Third Party

Hi, The following requirement is open with our client. Title : Computer Software Validation (CSV) Engineer Location : Santa Clara, CA (ONSITE) Duration : 12+ Months Relevant Experience (in Yrs.) : 8+ Job Description: 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 c, ISO 13485, IEC 62304).Experience with non-product software v

Medical Equipment Engineer I (verification/Validation)Job Title - Medical Equipment Engineer I (verification/Validation)

Estuate Inc.Company Name - Estuate Inc.

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Pleasanton, California, USA

Contract, Third Party

Job Summary After introduction to work processes, begins to organize, conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understanding.Assumes responsibility for the accuracy, quality, and timeliness of experimental results.Summarizes experimental results, and reviews conclusions with supervisors/project leader.Communicates results of experiments. Keeps supervisor/project leader informed of project status, particularly of sign

validation verification EngineerJob Title - validation verification Engineer

Data Systems Integration GroupCompany Name - Data Systems Integration Group

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Manassas, Virginia, USA

Third Party, Contract

Job Title: Sr. Systems Engineer Duration: 12+ month Work Location: Manassas, Viginia (Onsite daily) NOTE:** Candidate will need to go to Santa Clara for 3-4 weeks in beginning of project to train with the team. Primary Responsibilities 1. Perform prototype bring-ups, tackle tough system and board level issues. 2. Run system tests. Collect and report on testing results. Screen modules and boards as part of testing and debug. 3. Create and develop test plans for new features on each product. Recom

Silicon Validation EngineerJob Title - Silicon Validation Engineer

SivaltechCompany Name - Sivaltech

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San Jose, California, USA

Full-time, Third Party

Job Summary: We're looking for silicon validation engineers to drive pre-silicon and post-silicon validation of SerDes and High-Speed interfaces for automotive products. You'll develop test plans, test cases, and automation scripts using Python, and collaborate with design, DV, and firmware teams. Responsibilities: - Develop validation test plans and methodologies - Create test cases and automation scripts using Python - Develop low-level drivers for Windows and Linux OS - Collaborate with tea