Validation Engineer

3 weeks ago

Indianapolis, United States Kimball Electronics Full time

We are committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation during the application or recruitment process due to a disability, you may contact us at KEIrecruiting@Kimballelectronics.com. We will treat all requests for accommodations discreetly.

*Note: There is no Visa sponsorship being offered for this position.

Kimball Electronics does not accept agency resumes. Please do not forward resumes to any recruiting alias or employee. Kimball Electronics is not responsible for any fees related to unsolicited resumes.

We provide 3 weeks of PTO starting your 1st year in addition to 10 paid holidays. Annual profit sharing bonus based on company performance. Major health, dental, vision, and complementary insurances starting day 1. We offer a 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually and you are vested 100% immediately.

Quick Summary

As Validation Engineer for this contract medical device manufacturer, you are responsible for the development/authoring Validation Plans (VP) and protocols for all phases of the validation lifecycle Execution of test protocols and analysis of data using statistical techniques, tools and software. In addition, the Validation Engineer will be responsible for scheduling and hosting Validation Review meetings, reviewing and approving any validation documentation and the allocation of resources to support new or existing validation projects.

You should be able to manage projects that may compete for your time while keeping accurate records of work. In our business, it is critical you can demonstrate a solid understanding of the importance of quality and documentation with timely consistent and accurate records of work and possibly training other employees.

Basic Background Requirements

This position will require:

  • 3-5 years' experience in Medical Device manufacturing is key
  • Bachelor's degree in Engineering or Engineering Technology (Mechanical, Electrical, Biomedical)
  • Knowledgeable on ISO13485, regulatory requirements, and FDA 21 CFR 820/GMP Medical Device Regulations
  • Experience with different manufacturing processes, such as automated assembly lines, manual assembly processes, molding processes and packaging processes.
Basic Background Requirements(cont'd)
  • Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & GR&R's
  • Process development/characterization experience
  • Ability to analyze data through the use of statistical principals (e.g. process capability, normality test, GR&R, etc.) and statistical software (e.g. Minitab)
  • Ability to compose professional and engineering documentation (e.g. protocols, engineering studies, reports, etc.)
  • Ability to manage time and projects effectively while setting and meeting aggressive schedules
  • Quality oriented individual with a focus on making data driven decisions
  • Proficient with the use of Microsoft tools (Word, Excel, Project, Power Point, Visio)
  • Ability to understand business, legal and regulatory requirements
Key Performance Objectives

Short Term: (0 to 3 months)
  • Establish and participate in Validation Review meetings
  • Establish or review validation documentation to ensure it is in alignment with QS & regulatory requirements
  • Assists with or creates protocol & report generation for process & equipment validations
  • Work directly with medical device customers on a validation process
  • Analyze data statistically using mini-tab
  • Assist in validation efforts for commissioning of production systems
  • Maintain system documentation in support of FDA regulatory requirements
Midterm: (3 to 6 months)
  • Train other engineers on validation practices and techniques
  • Collect & share validation program data
  • Work with project/program managers in the execution of project plans
  • Lead the VRB meetings
  • Participate in Lean manufacturing training and projects
Long term: (6 to 12 months)
  • Champion the validation program by leading validation continuous improvement activities
  • Review and approve all validation protocols and reports
  • Provide training and guidance to other validation team members


Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Kimball Electronics we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles

We're proud to be an equal opportunity employer and consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition or disability or any other characteristic protected by applicable federal, state, or local law.

We will consider for employment qualified candidates with arrest and conviction records, consistent with applicable law (including, for example, the San Francisco Fair Chance Ordinance for roles based in San Francisco).

  • Validation Engineer

    1 month ago

    Indianapolis, United States PSC Biotech Full time

    Job DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....

  • Validation Engineer

    2 months ago

    Indianapolis, United States PSC Biotech Full time

    Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a...

  • Validation Engineer

    3 months ago

    Indianapolis, United States PSC Biotech Full time

    Job DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....

  • Validation Engineer

    2 months ago

    Indianapolis, United States PACIV Full time

    Job DescriptionJob DescriptionPACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).      Job Description:The Validation Engineer...

  • Validation Engineer

    1 week ago

    Indianapolis, United States PACIV Full time

    Job DescriptionJob DescriptionPACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).      Job Description:The Validation Engineer...

  • Senior Validation Engineer

    2 weeks ago

    Indianapolis, United States Disability Solutions Full time

    Senior Validation Engineer at Precision Medicine Group (View all jobs) Indianapolis, Indiana, United States Why Precision for Medicine? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are...

  • Senior Validation Engineer

    3 months ago

    Indianapolis, United States PSC Biotech Full time

    Job DescriptionJob DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....

  • Senior Validation Engineer

    3 months ago

    Indianapolis, United States PSC Biotech Full time

    Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a...

  • Validation and Verification Engineering Intern

    5 days ago

    Indianapolis, Indiana, United States Rolls-Royce Full time

    About the RoleWe are seeking a highly motivated and detail-oriented individual to join our team as a Validation and Verification Engineering Intern. As a member of our team, you will be responsible for ensuring the quality and reliability of our products by validating and verifying their design and functionality.Key ResponsibilitiesCollaborate with...

  • Validation Engineer I

    3 months ago

    Indianapolis, United States E2i Inc. Full time

    Job DescriptionJob DescriptionSalary: $70k-$80kE2i is a small systems integrator that specializes in automation, validation, informatics, control panel design, and fabrication for the last 32 years. Our mantra is Quality People. Quality Results. At E2i, self-growth is at the basis of many decisions.Working as a systems integrator, you will have the...

  • Senior Validation Engineer

    5 days ago

    Indianapolis, Indiana, United States Verista Full time

    About the RoleWe are seeking a highly skilled Senior Validation Engineer to join our team at Verista. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our products and services.Key ResponsibilitiesAuthoring, editing, and executing technical testing, commissioning, qualification, and validation...

  • Validation Engineer

    1 month ago

    Indianapolis, United States BioTalent Full time

    Job Title: CSV EngineerLocation: RemoteDuration: 12 months minimum Role Responsibilities:Alidating syncade, tulip, labVantage, Lab systems, Asher Systems/platforms, Power Bi. In this role you will help set up procedures and strategies to improve and make the systems more efficient.SME/ has 5-8 years experience.Strong experience with setting up procedures in...

  • Validation Engineer

    4 weeks ago

    Indianapolis, United States BioTalent Full time

    Job Title: CSV EngineerLocation: RemoteDuration: 12 months minimum Role Responsibilities:Alidating syncade, tulip, labVantage, Lab systems, Asher Systems/platforms, Power Bi. In this role you will help set up procedures and strategies to improve and make the systems more efficient.SME/ has 5-8 years experience.Strong experience with setting up procedures in...

  • CQV Engineer

    2 weeks ago

    Indianapolis, United States Verista Full time

    Job DescriptionJob DescriptionVerista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing...

  • Systems & Software Verification and Validation Engineer

    2 months ago

    Indianapolis, United States Belcan Corporation Full time

    Systems & Software Verification and Validation Engineer Job Number: 350610 Category: -Software & Systems SBU Description: A Systems & Software Validation and Verification Engineer job in Indianapolis, IN 46241 is currently available at Belcan. As a Systems & Software Verification and Validation Engineer you will have a focus on DO-178 validation and...

  • Validation Engineer

    2 months ago

    Indianapolis, United States PSC Biotech Full time

    Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a...

  • Systems & Software Verification & Validation Engineer

    1 month ago

    Indianapolis, United States Belcan Full time

    A Systems & Software Validation and Verification Engineer job in Indianapolis, IN 46241 is currently available at Belcan. As a Systems & Software Verification and Validation Engineer you will have a focus on DO-178 validation and verification (both at the System and Software levels). To be considered for this role, you will have a Bachelor's of Science...

  • Systems & Software Verification & Validation Engineer

    1 month ago

    Indianapolis, United States Belcan Full time

    A Systems & Software Validation and Verification Engineer job in Indianapolis, IN 46241 is currently available at Belcan. As a Systems & Software Verification and Validation Engineer you will have a focus on DO-178 validation and verification (both at the System and Software levels). To be considered for this role, you will have a Bachelor's of Science...

  • Validation Engineer

    3 months ago

    Indianapolis, United States PSC Biotech Corporation Full time

    Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements....

  • CQV / Validation Engineer

    3 months ago

    Indianapolis, United States Verista Full time

    Verista's 600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides...