Current jobs related to Senior Computer System Validation Engineer - College Station, Texas - BioPharma Consulting JAD Group

  • Senior Computer Systems Validation Engineer

    2 weeks ago

    College Station, Texas, United States Fujifilm Full time

    Job SummaryThe Senior Computer Systems Validation Engineer will be responsible for overseeing the validation of all GxP-regulated computerized systems at Fujifilm Diosynth Biotechnologies. This includes ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The ideal...

  • Senior Computerized Systems Validation Engineer

    2 weeks ago

    College Station, Texas, United States FUJIFILM Holdings America Corporation Full time

    Job SummaryThe Senior Computerized Systems Validation Engineer will be responsible for overseeing the validation of computerized systems at all applicable points of the lifecycle, ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesProvide oversight of validation activities and lead the development and approval of...

  • Senior CSV Validation Engineer

    7 days ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior CSV Validation Engineer to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.Key ResponsibilitiesProvide oversight of validation activities, including the...

  • Validation Specialist

    1 month ago

    College Station, Texas, United States Ellab - Validation & Monitoring Solutions Full time

    {"title": "Validation Engineer", "description": "Exciting Opportunity at EllabWe're seeking a skilled Validation Engineer to join our team and contribute to our mission of providing cutting-edge solutions.Key Responsibilities:Generate, obtain approvals, and execute validation deliverables for facilities, utilities, systems, and equipment.Validate various...

  • Validation Specialist

    2 weeks ago

    College Station, Texas, United States Ellab - Validation & Monitoring Solutions Full time

    Exciting Opportunity at Ellab - A Leader in Validation & Monitoring SolutionsWe're seeking a highly skilled Validation Specialist to join our vibrant team and embark on an exciting journey with us.As a frontrunner in the industry, Ellab is committed to providing cutting-edge benefits that make us stand out. Our Benefits Package includes: Time to Unwind:Enjoy...

  • Senior Systems Engineer

    2 weeks ago

    College Station, Texas, United States L3 Technologies Full time

    Job Title: Senior Systems Engineer - RF/EW (Active Secret Security Clearance Required)Job Code: 15869Job Location: State College, PAJob Description:As a Senior Systems Engineer for L3 Technologies, you will contribute to the development of cutting-edge technologies that deliver mission-critical solutions for our customers. In this role, you will lead overall...

  • Senior Systems Engineer

    2 weeks ago

    College Station, Texas, United States Applied Research Laboratory at the Penn State University Full time

    We are seeking a highly skilled Senior Systems Engineer to join our team at the Applied Research Laboratory (ARL) at Penn State University.As a Senior Systems Engineer in the Intelligent Sensors Technologies (IST) Department, you will be responsible for the analysis, design, development, and prototyping of sensor systems and networks for various government...

  • Senior Validation Specialist

    2 weeks ago

    College Station, Texas, United States Mentor Technical Group Full time

    Job DescriptionMentor Technical Group is seeking a highly skilled Senior Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our technical documentation and validation processes.Key Responsibilities:Develop and execute commissioning and qualification protocols for...

  • Validation Specialist

    1 week ago

    College Station, Texas, United States CPMNA Full time

    Job OverviewCPMNA is seeking a highly skilled Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our facilities, utilities, systems, and equipment meets regulatory requirements.Key ResponsibilitiesDevelop and execute validation protocols for FUSE systems and...

  • Validation Engineer III

    4 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Validation Engineer III FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a highly skilled Validation Engineer III to join our team. As a key member of our validation team, you will be responsible for planning and organizing validation activities across cross-functional groups, generating and executing validation deliverables, and ensuring...

  • Validation Engineer III

    2 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job Title: Validation Engineer III FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a highly skilled Validation Engineer III to join our team.Job Summary:We are looking for a talented individual to work in the biotechnology industry, providing and maintaining status updates for validation activities related to day-to-day operations or project work....

  • Validation Specialist

    2 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec, a global leader in system validation and lifecycle services, seeks a highly motivated and detail-oriented Validation Engineer to join its team in Texas. As a key member of the validation team, you will be responsible for ensuring the quality and integrity of computerized systems in the life sciences manufacturing environment.The ideal...

  • Validation Manager, CSV

    1 week ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryThe Manager, CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements at each of our 4...

  • Validation Engineer Level I

    2 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec, a global leader in system validation and lifecycle services, is seeking a skilled Validation Engineer Level I to join our team in Texas.As a key member of our life sciences organization, you will play a critical role in ensuring the quality and integrity of our clients' products. Your expertise in validation protocols, system impact...

  • Validation Engineer III

    2 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryWe are seeking a highly skilled Validation Engineer III to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our biotechnology products.Key ResponsibilitiesDevelop and execute validation plans and protocols to ensure compliance with...

  • Validation Manager, CSV

    2 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Job SummaryThe Manager, CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements at each of our 4...

  • Senior Systems Research and Development Engineer

    4 weeks ago

    College Station, Texas, United States Applied Research Laboratory at the Penn State University Full time

    Job Title: Senior Systems Research and Development EngineerWe are seeking a highly motivated and experienced Senior Systems Research and Development Engineer to join our team at the Applied Research Laboratory at Penn State University. This position will be working with senior technical staff to research, design, develop, integrate, and test advanced...

  • Senior Systems Research and Development Engineer

    2 weeks ago

    College Station, Texas, United States Applied Research Laboratory at the Penn State University Full time

    {"h1": "Senior Systems Research and Development Engineer", "p": "We are seeking a highly motivated and experienced Senior Systems Research and Development Engineer to join the Communications and Signal Processing (CSP) Division in the Applied Research Laboratory (ARL) at Penn State. This position will be working with senior technical staff to research,...

  • Automation Systems Engineer

    2 months ago

    College Station, Texas, United States G-CON Full time

    About the RoleG-CON is seeking a highly skilled Automation Systems Engineer to join our team. As an Automation Systems Engineer, you will be responsible for designing, developing, and implementing automation systems for our pharmaceutical clients.Key ResponsibilitiesAutomation System Design: Design and develop automation systems for HVAC, door interlocks,...

  • Validation Manager, CSV

    1 week ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    About the Role:The Validation Manager, CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements at each...

Senior Computer System Validation Engineer

2 months ago

College Station, Texas, United States BioPharma Consulting JAD Group Full time
Job Overview

Summary: BioPharma Consulting JAD Group is in search of a skilled and knowledgeable Senior Engineer specializing in Computer System Validation (CSV). This role is pivotal in ensuring adherence to regulatory standards and industry benchmarks for computerized systems utilized in pharmaceutical production.

Key Responsibilities:

  • Develop, secure approvals for, and implement validation documentation for computerized systems and associated infrastructure, including Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring compliance with regulatory and procedural standards such as 21 CFR Part-11, Annex-11 Data Integrity, and GAMP5.
  • Coordinate and manage validation initiatives across various functional teams, providing and maintaining updates on validation tasks related to routine operations or project assignments.
  • Review all System Delivery Life Cycle (SDLC) outputs, offering constructive insights and ensuring compliance with relevant Standard Operating Procedures (SOPs).
  • Create, assess, and revise SOPs, forms, templates, documentation, and files as necessary.
  • Act as a CSV subject matter expert during regulatory and client audits.
  • Foster strong relationships within the team and with other department leaders to enhance collaboration and efficiency.
  • Encourage team adaptability and responsiveness to both planned and unforeseen changes.
  • Conduct all responsibilities in a compliant and ethical manner, adhering to applicable laws, regulations, and industry standards.
  • Perform additional duties as required.

Required Skills & Qualifications:

  • Solid understanding of engineering principles.
  • Proficient knowledge and experience in computerized systems validation.
  • Experience with DCS, SCADA, and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, and Wonderware is preferred.
  • In-depth knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 standards, and FDA regulations.
  • Exceptional written and verbal communication abilities.
  • Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
  • Ability to work independently with minimal supervision (author protocols, execute tasks, analyze data, and draft reports).
  • Enthusiasm for working in a dynamic, cutting-edge research and customized manufacturing environment.

Educational Background:

  • Master’s Degree in Computer Science, Life Sciences, Engineering, or a related field with three (3) years of experience in computer system validation within the pharmaceutical or biotechnology sectors.
  • Bachelor’s Degree in Computer Science, Life Sciences, Engineering, or a related field with five (5) years of experience in computer system validation within the pharmaceutical or biotechnology sectors.
  • Associate’s Degree in Computer Science, Life Sciences, Engineering, or a related field with seven (7) years of experience in computer system validation within the pharmaceutical or biotechnology sectors.

Preferred Qualifications:

  • Familiarity with the DeltaV automation platform.
  • Experience in environments regulated by the FDA.