Talent.com

Validation manager Jobs in Indianapolis, IN

Last updated: 3 days ago
  • Promoted
Validation Engineer

Validation Engineer

Kimball ElectronicsIndianapolis, IN, United States
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 recruit...Show moreLast updated: 7 days ago
  • Promoted
Validation Engineer

Validation Engineer

PSC BiotechIndianapolis, IN, United States
Full-time
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 appl...Show moreLast updated: 8 days ago
  • Promoted
Validation Engineer

Validation Engineer

Precision Medicine GroupIndianapolis, IN, US
$58,000.00–$63,000.00 yearly
Full-time
Precision Medicine Group (View all jobs).Indianapolis, Indiana, United States.Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opp...Show moreLast updated: 3 days ago
  • Promoted
Validation Engineer

Validation Engineer

Project FarmaIndianapolis, IN, United States
$58,000.00–$63,000.00 yearly
Full-time
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 ...Show moreLast updated: 8 days ago
  • Promoted
Senior Validation Engineer

Senior Validation Engineer

Katalyst Healthcares and Life SciencesIndianapolis, IN, United States
Full-time
Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. Draft, review, author, and deploy a...Show moreLast updated: 8 days ago
  • Promoted
Supervisor, Inventory Validation

Supervisor, Inventory Validation

TRIMEDXIndianapolis, IN, United States
Full-time
If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care an...Show moreLast updated: 30+ days ago
  • Promoted
Validation Engineer - Indianapolis

Validation Engineer - Indianapolis

PACIVIndianapolis, IN, United States
Full-time
PACIV, 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...Show moreLast updated: 8 days ago
  • Promoted
Validation Engineer

Validation Engineer

Insight GlobalIndianapolis, IN, United States
Full-time
Insight Global is looking for a mechanical or electrical engineer with validation experience.Any kind of HVAC experience is a plus. Will develop documentation / blueprints / designs and sequences of ope...Show moreLast updated: 8 days ago
  • Promoted
5510- Logistics Technical Writer / Validation Engineer

5510- Logistics Technical Writer / Validation Engineer

Verista, Inc.Indianapolis, IN, US
$59,951.00–$85,000.00 yearly
Full-time
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 heal...Show moreLast updated: 7 days ago
  • Promoted
Validation Engineer I

Validation Engineer I

Bristol-Myers SquibbIndianapolis, IN, United States
Full-time
Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...Show moreLast updated: 7 days ago
Validation Lead

Validation Lead

Tata Consultancy ServicesIndianapolis, IN
Required •Minimum of 10 years’ experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with...Show moreLast updated: 30+ days ago
Validation Engineer

Validation Engineer

PSC Biotech CorporationIndianapolis, Indiana, United States
Full-time
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 appl...Show moreLast updated: 30+ days ago
  • Promoted
Process & Validation Expert

Process & Validation Expert

Novartis Group CompaniesIndianapolis, IN, United States
$97,600.00–$146,400.00 yearly
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer pat...Show moreLast updated: 30+ days ago
  • Promoted
Validation Engineer

Validation Engineer

Precision for MedicineIndianapolis, IN, United States
$58,000.00–$63,000.00 yearly
Full-time
Validation Engineerat Precision Medicine Group (View all jobs)Indianapolis, Indiana, United StatesWhy Precision for Medicine?Welcome to the forefront of innovation in cutting edge patient treatment...Show moreLast updated: 15 days ago
  • Promoted
Validation Specialist

Validation Specialist

PTS DiagnosticsIndianapolis, IN, US
Full-time
The Validation Specialist is responsible for ensuring that PTS medical devices, manufacturing processes, equipment, and systems, comply with industry standards and regulations.ESSENTIAL DUTIES AND ...Show moreLast updated: 3 days ago
Validation Lead

Validation Lead

Katalyst HealthCares & Life SciencesIndianapolis, IN
Work in partnership with the Global IT team and site representatives to understand business needs and implement innovative solutions to add value to the site while maintaining computer systems in a...Show moreLast updated: 30+ days ago
  • Promoted
Model Validation Manager

Model Validation Manager

VirtualVocationsIndianapolis, Indiana, United States
Full-time
A company is looking for a Model Validation Manager responsible for managing the validations of quantitative models in support of economic and regulatory requirements. Key ResponsibilitiesManage the...Show moreLast updated: 4 days ago
Senior Validation Engineer

Senior Validation Engineer

Chipton-RossIndianapolis, IN
$35.00–$40.00 hourly
Full-time
Industry SCI Region IN-Indiana City Indianapolis State IN Rate $35 to $40.DOE Duration 9 Months Description.Chipton-Ross is seeking a Senior Validation Engineer for a contract opportunity in Indian...Show moreLast updated: 30+ days ago
Validation Engineer II

Validation Engineer II

Merck KGaA, Darmstadt, GermanyIndianapolis, United States
The Validation Engineer II is responsible for providing support to all validation activities within the Indianapolis site. This position is responsible for compliance with all applicable cGMP, FDA, ...Show moreLast updated: 30+ days ago
Validation Engineer

Validation Engineer

Kimball ElectronicsIndianapolis, IN, United States
7 days ago
Job type
  • Full-time
Job description

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 [email protected]. 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).