Validation Engineer

3 weeks ago


Columbus, United States The Fountain Group Full time

Pay $66/HR to $78/HR


Currently seeking a Validation Engineer for a global, premiere healthcare leader with a portfolio of life-changing technologies and products in diagnostics, medical devices, nutritionals and branded generic medicines.


This is an onsite position in Columbus, OH – NOT a remote opportunity. W2 only, no C2C entertained.


We are currently seeking a dedicated Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring compliance with FDA regulations and standards, particularly focusing on 21 CFR Part 11 compliance. Your primary responsibilities will include drafting, documenting, and executing validation protocols for new process equipment and packaging equipment, with a strong emphasis on sterilization and compliance.


Key Responsibilities:

  • Drafting and documenting validation protocols in accordance with FDA regulations, including but not limited to User Requirements Specifications (URS), Failure Mode and Effects Analysis (FMEA), Software Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Design Qualifications (DQ).
  • Collaborating closely with site engineers to ensure detailed engineering requirements are met throughout the validation process.
  • Utilizing a V model validation approach to ensure comprehensive validation coverage.
  • Partnering with relevant stakeholders to obtain approval for validation documentation.
  • Supporting the execution and sign-off of validation documentation for equipment validation processes.
  • Proficiently using tools such as M-Files and MS Project to manage documentation and project timelines.


Qualifications:

  • Bachelor's degree in Engineering or related field.
  • Seeking 5+ years of experience in a Validation role, ideally within FDA regulated industries, preferably in the medical device or pharmaceutical sector.
  • Strong understanding of FDA regulations and standards, particularly 21 CFR Part 11 compliance.
  • Experience with drafting and documenting validation protocols, including URS, FMEA, SIA, DQ, and IQ/OQ/PQ documentation.
  • Familiarity with M-Files and MS Project is advantageous.
  • Excellent communication and collaboration skills, with the ability to work effectively in a team environment.
  • Detail-oriented with a commitment to ensuring accuracy and compliance in validation processes.
  • Ability to adapt to changing priorities and manage multiple tasks concurrently.


  • Validation Engineer

    3 days ago


    Columbus, United States Collabera Full time

    Description Home Search Jobs Job Description Validation Engineer Contract: Columbus , Ohio, US Salary: $65.00 Per Hour Job Code: 349232 End Date: 2024-06-08 Days Left: 13 days, 3 hours left Apply Responsibilities: Will lead the effort with stakeholders, SMEs, and external vendors in Design Qualification (DQ) phase to create the following deliverables,...

  • Validation Engineer

    5 days ago


    Columbus, United States Collabera Full time

    Description Home Search Jobs Job Description Validation Engineer Contract: Columbus , Ohio, US Salary: $65.00 Per Hour Job Code: 349232 End Date: 2024-06-08 Days Left: 14 days, 3 hours left Apply Responsibilities: Will lead the effort with stakeholders, SMEs, and external vendors in Design Qualification (DQ) phase to create the following deliverables,...

  • Validation Engineer

    13 hours ago


    Columbus, United States Collabera Full time

    Description Home Search Jobs Job Description Validation Engineer Contract: Columbus , Ohio, US Salary: $65.00 Per Hour Job Code: 349232 End Date: 2024-06-08 Days Left: 11 days, 3 hours left Apply Responsibilities: Will lead the effort with stakeholders, SMEs, and external vendors in Design Qualification (DQ) phase to create the following deliverables,...

  • Validation Engineer

    4 days ago


    Columbus, United States Forge Biologics Full time

    Job DescriptionJob DescriptionAbout Forge Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient...


  • Columbus, United States Spectraforce Technologies Full time

    Job Title: Validation Engineer III Duration: 12 Months Location: Columbus, OH 43201 Shift: 8 am - 5 pm Jos Description Position Overview: Validation support for project execution Drafting documentation, FDA compliance for new packaging equipment Documentation FMEA, SIEA, functional requirements, operation qualification, V model. Partner up with site...


  • Columbus, United States INTELLECTT INC Full time

    Role : Validation Engineer III((Software/equipment)) Location : Columbus, OH - 43219 Duration : 12 Months on W2 Job Description: - Candidates must possess 3-7 years of experience supporting validation programs and possess a BS degree preferably in the Science or Engineering fields (or equivalent experience). - Give attention to detail, perform critical...


  • Columbus, United States Abbott Laboratories Full time

    Nourish the world and your career as part of the Nutrition team at Abbott.Our business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®,...


  • Columbus, Ohio, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Nourish the...


  • Columbus, United States Johnson Electric Full time

    Come Innovate MedTech with us! The Senior Quality Engineer for Vandalia, OH., will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure...


  • Columbus, United States Forge Biologics Full time

    Job DescriptionJob DescriptionAbout Forge Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient...


  • Columbus, United States Forge Biologics Inc. Full time

    JOB POSTING About Forge Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality . We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring...


  • Columbus, United States Forge Biologics Full time

    About Forge Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in...

  • Lead CQV Engineer

    1 month ago


    Columbus, United States LS Solutions Full time

    Job Title: Lead CQV Engineer/Analyst Location: Columbus, OHJob Type : Full Time JOB DESCRIPTIONLead CQV Engineer/AnalystThis role is 100% onsite at the Easton, OH location. The role requires strong validation skills and experience as well as strong people and communication skills. The position will support multiple projects across all of the Client's...

  • Lead CQV Engineer

    1 month ago


    Columbus, United States LS Solutions Full time

    Job Title: Lead CQV Engineer/Analyst Location: Columbus, OHJob Type : Full Time JOB DESCRIPTIONLead CQV Engineer/AnalystThis role is 100% onsite at the Easton, OH location. The role requires strong validation skills and experience as well as strong people and communication skills. The position will support multiple projects across all of the Client's...

  • Lead CQV Engineer

    1 month ago


    Columbus, United States LS Solutions Full time

    Job Title: Lead CQV Engineer/Analyst Location: Columbus, OHJob Type : Full Time JOB DESCRIPTIONLead CQV Engineer/AnalystThis role is 100% onsite at the Easton, OH location. The role requires strong validation skills and experience as well as strong people and communication skills. The position will support multiple projects across all of the Client's...


  • Columbus, United States LER TechForce, LLC. Full time

    Engine Feature Test, Calibration and Tuning Engineer Are you looking for a role where you can use your knowledge of engine controls and tune features help engine performance and reduce emissions into the environment? Would you like to work for a company that provides an innovative work environment, flexible schedules, and ongoing professional development?...


  • Columbus, United States Ultimate Solutions Full time

    Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries in Puerto Rico, the United States, and Europe. Over 15 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical,...

  • Geotechnical Engineer

    3 weeks ago


    Columbus, United States Insight Global Full time

    Insight Global is looking for a Geotechnical Engineer. Geotechnical Engineers will provide engineering and consulting services for focused Georgia/Alabama based projects and clients. This person will be responsible for set up of projects coming in, setting up and monitoring drilling on job site, and sending lab testing's for evaluation of soil. They will...

  • Software Engineer

    4 weeks ago


    Columbus, Ohio, United States codesbright Full time

    Responsibilities Role entails an interdisciplinary field of software engineering and engineering management controlling techniques and software involved with design integration and sustainment of complex systems over their life cycles. Focus is on design and code new software or modify existing software. Assist with developing test procedures and...


  • Columbus, United States LER TechForce Full time

    Engine Feature Test, Calibration and Tuning Engineer Are you looking for a role where you can use your knowledge of engine controls and tune features help engine performance and reduce emissions into the environment? Would you like to work for a company that provides an innovative work environment, flexible schedules, and ongoing professional...