process validation engineer Jobs

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Process Validation Engineer

Pyramid Consulting, Inc.

Swiftwater, Pennsylvania, USA

Contract

Immediate need for a talented Process Validation Engineer. This is a 12+ months contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-70991 Pay Range: $60 - $64/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Manager Notes: Day in t

Process Validation Engineer

Tranzeal, Inc.

Tucson, Arizona, USA

Contract

Role: Process Validation EngineerLocation: Tucson, AZ Description:We are seeking a highly motivated and detail-oriented Process Validation Engineer with 1-3 years of experience to join our team. The Process Validation Engineer will be responsible for developing and executing process validation and/or process verification protocols and reports to ensure that manufacturing processes are compliant with regulatory requirements and company standards. This role involves collaborating with cross-functi

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Pittsburgh, Pennsylvania, USA

Full-time

Roles & Responsibilities: They have a project to validate some of their new printers and prefer to use contractors to complete the 6-month project. The Senior Process Validation engineer will be in charge of procedure changes, validation efforts for existing processes and the changes created during this time. They are expected to have experience writing procedures and validating some printers, while validating some of the software pieces to the printers. 7-12+ Years of experience with Proc

Process Validation Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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

Process Validation Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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

Sr. Process Validation Engineer

Katalyst Healthcares and Lifesciences

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

Validation Process Engineer

Altitude Technology Solutions Inc

Irvine, California, USA

Contract

Urgent Role Validation Process Engineer Irvine, CA onsite Contract Role Keywords NPD, NPI, Process & product development, Process and Equipment Validation, Process Characterization, good manufacturing practices and documentation, Process Improvement GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs Knowledge in Experiment design and SPC Management of statistical procedures Strong creative, analytical and problem-solving skills

Principal Process Controls & Validation Engineer

Regeneron Pharmaceutical

Remote or 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

Validation Engineer

Stefanini

Minneapolis, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Validation Engineer in Plymouth, MN For quick Apply, please reach out to Sangeeta Dasadhikary- call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN Shift: 1st Shift Responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system

Sr. Staff Post Silicon Validation Engineer - Direct hire/Full time (Onsite)

Maxonic, Inc.

Austin, Texas, USA

Full-time

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Staff Post Silicon Validation Engineer Job Description: Job Title: Sr. Staff Post Silicon Validation Engineer Job Type: Fulltime Job Location: Austin, TX or Palo Alto, CA Work Schedule: Onsite 5 days a week The candidate will focus on developing Post-Silicon validation plan, debug tools, and infrastructure for a custom SoCs and Platform designs for Autopilot and AI. As

Pre/Post Silicon Validation Engineer

E-Solutions, Inc.

Sunnyvale, California, USA

Full-time

Job Role- Pre/Post Silicon Validation Engineer Location: Sunnyvale, CA or Redmond, WA (Onsite) Post-Silicon Validation Required Job Responsibilities: Responsible for SoC and E2E system validation plan development, and execution Execute silicon bring-up and validation activities across multiple SoCs. Understand system HW/SW/FW component as a whole and do test execution and debugging Power and performance characterization on pre-silicon platforms and post-silicon validation boards Able to wor

Urgent Opening- QA Validation Engineer - Cypress, CA

SunRay Enterprise Inc

Cypress, California, USA

Contract

Hello Professional, Hope you are doing well. This is Dharm from Sunray Corporation I found your resume suitable for one of the prime position with one of our client. Please find below the job description and let me know if you would be comfortable with Role : QA Validation EngineerLocation : Cypress, CADuration : 9+ Months Role OverviewExperience in Pharmaceutical Manufacturing, Biotechnology, and Medical device companies Performed Computer System Validation of cloud/server-based systemsInvol

PSV PCIE Validation & Emulation Engineer

Wise Equation Solutions Inc.

San Jose, California, USA

Contract

Job Title: PSV PCIE Validation & Emulation Engineer Location: San Jose, CA (Onsite) Hiring Type: W2 Contract Job Description: Good knowledge and understanding of PCIe Architecture, Validation, Debug Experience.Exposure to PCIe BAR and IOMMU architectureDevelop the critical pieces of EAI Firmware used to deploy inference jobs on EAI processorsAdvanced programming skills in C/C++ for operating system kernel & systems developmentUnderstanding of RISC-V architecture is a plusDeep understanding of op

Validation Engineer

Shimento, Inc.

Portsmouth, New Hampshire, USA

Contract

Title: Analytical Validation Specialist IV Location: Portsmouth, NH Long Term Oniste Lead validation activities for analytical equipment, including software updates, new installations, and decommissioning.Act as Subject Matter Expert (SME) for analytical systems across Quality Control, Manufacturing, and other departments.Plan and execute validation protocols (IQ/OQ/PQ) for equipment and system changes.Manage and maintain TW records, including Change Controls, CAPAs, and Deviations.Create and r

Quality Assurance Engineer - Process and Validation

Civica Rx

Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs