Computer System Validation

4 weeks ago

College Station, United States CPMNA Full time
Job DescriptionJob DescriptionSalary:

The Computer System Validation (CSV) Senior Engineer, under general direction, will be responsible for 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. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.


Essential Functions:

  • Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
  • Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
  • Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
  • Must be able to create, review, and update SOPs, forms, templates, documentation, and files.
  • Supports regulatory and client audits as CSV subject matter expert.
  • Actively works to establish strong relationships within the group and with other department managers to improve harmonization and effectiveness.
  • Motivates team to be flexible and to respond to planned and unplanned or unanticipated changes with speed and confidence.
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
  • Perform other duties as assigned.


Required Skills & Abilities:

  • Working knowledge of engineering principles.
  • Working knowledge and expertise in computerized systems validation.
  • Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
  • Thorough knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
  • Ability to work with minimal supervision and independently at times (author protocol, execute, analyze data, author reports).
  • Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.


Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged standing, some bending, stooping, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Working on ladders.
  • Attendance is mandatory.


Qualifications:

  • Master of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with three (3) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Bachelor of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with five (5) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with seven (7) years of experience in computer system validation activities in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

Preferred Qualifications:

Knowledge of DeltaV automation platform

  • Computer System Validation Specialist

    2 weeks ago

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

    Exciting Career Opportunity at Ellab - Validation & Monitoring SolutionsWe are looking for a Computer System Validation/Data Integrity Specialist to become a vital part of our dynamic organization and engage in a rewarding professional journey.As a leader in our industry, Ellab is dedicated to offering exceptional benefits that distinguish us from the...

  • Senior Computer System Validation Engineer

    2 weeks ago

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

    Job OverviewSummary: 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...

  • Lead Computer Systems Validation Specialist

    2 weeks ago

    College Station, Texas, United States FUJIFILM Corporation Full time

    Position OverviewAt FUJIFILM Corporation, we recognize the significance of our work in the biopharmaceutical sector, and we are eager to welcome skilled professionals to our team. We are expanding our operations and capabilities, seeking dedicated individuals who are passionate about making a meaningful impact in healthcare. Join us in our mission to develop...

  • Senior Engineer

    2 weeks ago

    College Station, Texas, United States CPMNA Full time

    Job OverviewAs a Senior Engineer in Computer System Validation at CPMNA, you will play a pivotal role in overseeing GxP-Regulated Computerized Systems throughout their lifecycle. Your primary focus will be ensuring adherence to regulatory standards, CSV protocols, and Data Integrity requirements.Key Responsibilities:Develop, obtain approvals for, and execute...

  • Computer System Validation

    2 months ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a talented and experienced Computer System Validation (CSV) Senior Engineer to join our team. As a CSV Senior Engineer, you will play a critical role in ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical...

  • Computer System Validation

    4 weeks ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a talented and experienced Computer System Validation (CSV) Senior Engineer to join our team. As a CSV Senior Engineer, you will play a critical role in ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical...

  • Computer System Validation

    4 weeks ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work...

  • Computer System Validation

    2 months ago

    College Station, United States BioPharma Consulting JAD Group Full time

    Job DescriptionJob DescriptionSummary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work...

  • Validation Engineer

    2 months ago

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

    Exciting Opportunity at Ellab - Join Our Team! We're seeking a Validation Engineer to join our vibrant team and embark on an exciting journey with us.As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy: ️ Time to Unwind:Kick off your journey with 2 weeks of vacation (3 weeks at your...

  • Validation Engineer

    2 months ago

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

    🌟 Exciting Opportunity at Ellab - Join Our Team! 🌟We're seeking a Validation Engineer to join our vibrant team and embark on an exciting journey with us.As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy:🏖️ Time to Unwind:Kick off your journey with 2 weeks of vacation (3...

  • Lead Engineer for Computerized Systems Validation

    1 week ago

    College Station, Texas, United States CPMNA Full time

    Job OverviewSalary: The Senior Engineer for Computer System Validation (CSV) will operate under general supervision, taking charge of all GxP-Regulated Computerized Systems throughout the entire lifecycle of these systems. This role is crucial in ensuring adherence to regulatory standards, CSV protocols, and Data Integrity requirements.Key Responsibilities:...

  • Validation Engineer for Computerized Systems

    1 week ago

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

    Overview: BioPharma Consulting JAD Group is in search of a Validation Engineer specializing in Computer Systems to enhance our operations. In this role, you will be tasked with ensuring adherence to regulatory standards and industry practices for computerized systems utilized in pharmaceutical production. Your collaboration with diverse teams will be...

  • Automation Validation Engineer

    2 weeks ago

    College Station, Texas, United States Salent Solutions Full time

    Job OverviewPosition: Automation Validation EngineerCompany: Salent SolutionsCompensation: Competitive based on experienceAbout the Role:Salent Solutions is dedicated to delivering exceptional commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment to quality service supports organizations...

  • Automation Validation Engineer

    2 weeks ago

    College Station, Texas, United States Salent Solutions Full time

    CSV Engineer - Automation Company: Salent Solutions Compensation: Commensurate with Experience About this opportunity: Salent Solutions is dedicated to providing commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment lies in delivering exceptional service to organizations that develop...

  • Validation Engineer

    2 months ago

    College Station, United States Valspec Full time

    Job DescriptionJob DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle...

  • Validation Specialist

    2 days ago

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

    Job SummaryMentor Technical Group is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our clients' equipment and systems throughout their lifecycle.Key ResponsibilitiesDevelop and execute commissioning, qualification, and validation protocols for...

  • Quality Assurance Validation Engineer

    2 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec, a prominent global provider of system validation and lifecycle services, is dedicated to delivering commissioning and qualification of computerized systems for clients within the Life Sciences sector. Our mission, established in 1999, is to offer a comprehensive range of services that assist our clients in achieving their capital project...

  • Regulatory Compliance Validation Expert

    2 weeks ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec—a worldwide leader in system validation and lifecycle services—offers commissioning and qualification of computerized systems for clients in the Life Sciences sector. Founded in 1999, Valspec is dedicated to delivering a comprehensive range of services that assist clients in achieving their capital project and lifecycle maintenance...

  • Quality Assurance Validation Specialist

    7 days ago

    College Station, Texas, United States Valspec Full time

    Job OverviewValspec—a prominent global provider of system validation and lifecycle services—specializes in the commissioning and qualification of computerized systems for clients in the Life Sciences sector. Since its inception in 1999, Valspec has dedicated itself to delivering a comprehensive range of services that assist clients in achieving their...

  • Data Integrity Specialist

    2 months ago

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

    🌟 Exciting Opportunity at Ellab - Join Our Team! 🌟We're seeking a Computer System Validation/ Data Integrity Specialist to join our vibrant team and embark on an exciting journey with us.As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy:🏖️ Time to Unwind:Kick off your...