Validation Engineer jobs in North Carolina

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Validation Engineer
  • Sequoia Biotech
  • Raleigh, NC FULL_TIME
  • Sequoia Consulting Group provides world-class consulting services to the life sciences industry. Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatory affairs and validation at a variety of clients within the biotechnology industry.

    Sequoia's hands-on consultants provide technical knowledge and relevant life science experience to establish best practices in manufacturing, pharmaceutical and medical device companies. We are helping to produce better, faster and more economically priced medicines and medical devices around the world.

    Validation Engineer

    Position Overview: We are looking for a talented and detail-oriented Validation Engineer to execute and oversee validation activities within our clients’ pharmaceutical manufacturing facilities. The Validation Engineer will be responsible for planning, executing, and documenting validation protocols, ensuring that equipment, processes, and systems operate efficiently, reliably, and in compliance with regulatory requirements.

    Responsibilities:

    1. Validation Planning:
      • Develop validation master plans and protocols for equipment, processes, and systems used in pharmaceutical manufacturing.
      • Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.
    2. Validation Execution:
      • Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment and processes.
      • Conduct risk assessments and validation studies to identify potential issues and implement corrective and preventive actions.
    3. Documentation and Reporting:
      • Maintain accurate and detailed validation documentation, ensuring compliance with regulatory standards and internal procedures.
      • Prepare validation reports summarizing findings, conclusions, and recommendations for stakeholders and regulatory submissions.
    4. Change Control and Impact Assessment:
      • Assess the impact of proposed changes to equipment, processes, or systems on validation status.
      • Manage change control processes, ensuring that changes are properly evaluated, documented, and validated to maintain compliance.
    5. Collaboration and Training:
      • Collaborate with engineering, quality, and production teams to implement validation requirements for new equipment and processes.
      • Provide training and guidance to staff on validation procedures, documentation practices, and regulatory compliance requirements.
    6. Continuous Improvement:
      • Stay updated on industry trends, regulatory guidelines, and best practices related to validation activities.
      • Identify opportunities for process improvements and implement best practices to enhance validation efficiency and effectiveness.

     

    Qualifications:

    • Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.
    • Experience in commissioning, qualification, and validation in a regulated industry
    • Hands-on startup, commissioning, and qualification experience with one or more of the following systems: HVAC, Water-for-Injection, Autoclaves, Glasswashers, CIP, Bioreactors, Chromatography systems, Filtration systems
    • Strong project management skills, including the ability to manage multiple projects simultaneously.
    • Excellent problem-solving abilities and attention to detail.
    • Effective communication skills and ability to work collaboratively in a team-oriented environment.

     

    Sequoia offers a comprehensive suite of benefits including medical, dental, vision coverage, 401k, and company paid life-insurance.

    Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. Unfortunately, Sequoia is unable to provide any visa sponsorship at this time.

    All your information will be kept confidential according to EEO guidelines.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

  • 21 Days Ago

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Validation Engineer
  • Quality Chemical Laboratories
  • Hanover, NC FULL_TIME
  • Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This positio...
  • 24 Days Ago

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Validation Engineer
  • CAI
  • Raleigh, NC FULL_TIME
  • About CAI CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management a...
  • 7 Days Ago

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Validation Engineer
  • Hughes Engineering & Consulting
  • Raleigh, NC FULL_TIME
  • DescriptionHughes Engineering & Consulting is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industr...
  • 13 Days Ago

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Validation Engineer
  • krg technology inc
  • North, NC FULL_TIME
  • Company DescriptionRahulrahul(at) krgtech(dot)comKRG Technologies Inc.25000 | Avenue Stanford | Suite 253 | Valencia, CA 91355661-367-8000 EXT-215Job DescriptionJob Description:Mandatory Skills: Expo...
  • 14 Days Ago

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Validation Engineer
  • Global Channel Management, Inc.
  • Rocky, NC FULL_TIME
  • Company DescriptionGlobal Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of e...
  • 15 Days Ago

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Process Validation Engineer
  • Katalyst Healthcares & Life Sciences
  • Austin, TX
  • Responsibilities: Defines validation strategy and requirements and ensure implementation. Review and approve validation ...
  • 3/28/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Project Farma
  • Bethesda, MD
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 3/28/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Precision for Medicine
  • Raleigh, NC
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 3/28/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Project Farma
  • Alexandria, VA
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 3/28/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Precision Medicine Group
  • Raleigh, NC
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 3/28/2024 12:00:00 AM

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Process/Validation Engineer
  • Katalyst HealthCares and Life Sciences
  • Durham, NC
  • Responsibilities: Validation Planning: Develop and implement validation strategies, including process, equipment, and cl...
  • 3/25/2024 12:00:00 AM

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Global Product Validation Engineer
  • Trimble
  • Dayton, OH
  • Your Title: Global Product Validation Engineer Job Location: Dayton, Ohio - Christchurch, New Zealand - Chennai, India O...
  • 3/25/2024 12:00:00 AM

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Project Engineer, Validation Engineering
  • Precision Medicine Group
  • Alexandria, VA
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry....
  • 3/24/2024 12:00:00 AM

North Carolina (/ˌkærəˈlaɪnə/ (listen)) is a state in the southeastern region of the United States. It borders South Carolina and Georgia to the south, Tennessee to the west, Virginia to the north, and the Atlantic Ocean to the east. North Carolina is the 28th-most extensive and the 9th-most populous of the U.S. states. The state is divided into 100 counties. The capital is Raleigh, which along with Durham and Chapel Hill is home to the largest research park in the United States (Research Triangle Park). The most populous municipality is Charlotte, which is the second-largest banking center in...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$53,536 to $71,523

Validation Engineer in Muskegon, MI
As the Process Validation Engineer you will perform process validation activities to ensure cGMP requirements are met with regards to the IQ, OQ and PQs.
February 08, 2020
Validation Engineer in Ogden, UT
Knowledge of system validation “life-cycle” concept.
February 17, 2020
Validation Engineer in Baton Rouge, LA
There are validation engineer job opportunities across the entire industry including pharmaceutical, biotechnology and medical devices companies.
December 18, 2019