Talent.com
Katalyst HealthCares & Life Sciences
Validation EngineerKatalyst HealthCares & Life Sciences • Warsaw, IN
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life Sciences • Warsaw, IN
30+ days ago
Job type
  • Full-time
Job description

Summary:
Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices.
Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.
Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.
Roles & Responsibilities:
  • Lead, Develop and execute validation activities for CNC machines (, mills, lathes, multi-axis CNCs) and associated tooling/work holding.
  • Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.
  • Proficiency in developing and executing IQ/OQ/PQ protocols.
    Experience with metrology, calibration, and measurement system analysis.
    Knowledge of CNC machines, CAM software, and basic CNC programming concepts.
    Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
    Document control and eQMS systems experience (, MasterControl, ETQ, etc.).
  • Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO , GMP, CFR Part ).
  • Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.
  • Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment.
  • Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control.
  • Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances.
  • Support supplier qualification and acceptance tests for CNC-related components and tooling.
  • Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits.
  • Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes.
  • Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance.
Education & Experience:
  • Education: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
  • – years in CNC manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).
  • Regulatory & Standards: Strong knowledge of ISO , GMP, and CFR Part ; familiarity with risk management (ISO ) and validation concepts (IQ/OQ/PQ).

Create a job alert for this search

Validation Engineer • Warsaw, IN

Similar jobs

Quality Manager

CFSElkhart, IN, US
Full-time

This individual will be responsible for developing and maintaining quality systems, driving continuous improvement, ensuring customer satisfaction, and partnering with production teams to deliver h... Show more

 • Promoted

2nd Shift - Entry Level Manufacturing Associate (3P-11P)

Helios Hydraulics AmericaMishawaka, IN, United States
Full-time

Incentives:Bonus:5% Quarterly Bonus Program 401K:100% Matching 6% Tuition Reimbursement:100% of In-State Accredited Approved Program Health, Dental, and Vision:Extremely affordable and market leadi... Show more

 • Promoted

Travel Cath Lab Tech - $2664.4 / Week

FlexCareElkhart, IN, US
Full-time

FlexCare is seeking an experienced Cath Lab Tech for an exciting Travel Allied job in Elkhart, IN.Shift: 4x10 hr days Start Date: ASAP Duration: 13 weeks Pay: $2664.Why Clinicians Choose FlexCare.L... Show more

 • Promoted

Plant CI and Q - Excellence Group Leader

Talent Management GroupWarsaw, IN, United States
Full-time

We are looking for a highly skilled and motivated Plant CI Q-Excellence Lead to join our client's Quality team in their automotive plant.In this role, you will be a key technical leader responsibl... Show more

 • Promoted

Senior Software Engineer - Remote & Impactful

CroweElkhart, IN, United States
Remote
Full-time

A leading professional services firm is seeking a Senior Software Engineer to join their Product Engineering team in Elkhart, Indiana.The role involves developing software in an agile/scrum environ... Show more

 • Promoted

Construction Evaluator

McGrath IncElkhart, IN, United States
Permanent

The specific pay rate and level will depend on the successful candidate's qualifications, prior experience and location.PerksDailyPay Available!! Make any day a payday - You deserve to get paid any... Show more

 • Promoted

SITE ENGINEERING & DEVELOPMENT SYSTEM PROFESSIONAL - BMS

OP MobilityElkhart, IN, US
$40.00 hourly
Full-time

Ready to take on meaningful challenges and shape the next generation of mobility? Joining OPmobility means stepping into a global group with a purpose to keep people and goods moving safely, smarte... Show more

 • Promoted

Medical Billing and Coding - Entry Level Training Program

Dreambound Inc.Warsaw, Indiana, US
Full-time

Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more

 • Promoted

Manufacturing Engineer I

LanceSoft IncWarsaw, IN, United States
Full-time

Title: Manufacturing Engineer I.Bachelor's Degree and 0 years of relevant experience, or Associate's Degree and 2 years of relevant experience, or High School Diploma or Equivalent and 4 years of r... Show more

 • Promoted

Travel Cath Lab Tech - $2548 / Week

Premier Medical Staffing Services, LLCElkhart, IN, US
Full-time

Premier Medical Staffing Services, LLC is seeking an experienced Cath Lab Tech for an exciting Travel Allied job in Elkhart, IN.Shift: 4x10 hr days Start Date: 08/10/2026 Duration: 13 weeks Pay: $2... Show more

 • Promoted

Quality Verification and Vehicle Acceptance Superintendent

AM GeneralMishawaka, IN, United States
Full-time

INTRODUCTION TO AM GENERALAM General develops and builds specialized ground vehicle systems that get the US Armed Services and our allies to and from their mission safely.Our innovative spirit deli... Show more

 • Promoted

Senior Software Engineer - Rust & Cloud (Remote or NZ)

PropellerheadWarsaw, IN, United States
Remote
Full-time

A leading software services company is seeking a Senior Software Developer to join their team.The role emphasizes collaboration, technical excellence, and a hybrid working model.Applicants should h... Show more

 • Promoted

Travel Cath Lab Tech - $2548 / Week

Ventura MedStaffElkhart, IN, US
Full-time

Ventura MedStaff is seeking an experienced Cath Lab Tech for an exciting Travel Allied job in Elkhart, IN.Shift: Inquire Start Date: 08/10/2026 Duration: 13 weeks Pay: $2548 / Week.Founded in 2018 ... Show more

 • Promoted

Manufacturing Quality Engineer, Seats

Slate AutoWarsaw, IN, United States
Full-time

ABOUT SLATEAt Slate, we're building safe, reliable vehicles that people can afford, personalize and love-and doing it here in the USA as part of our commitment to reindustrialization.The spirit of ... Show more

 • Promoted

Remote Support Engineer - Esri/3-GIS Upgrades & Training

SSP Innovations LLCWarsaw, IN, United States
Remote
Full-time

A leading software firm located in Indiana is seeking a Customer Support Specialist to provide superior customer support for 3-GIS software.The ideal candidate will have a bachelor's degree, with a... Show more

 • Promoted

Travel Cath Lab Tech - $2430.4 / Week

CrossMed HealthcareElkhart, IN, US
Full-time

CrossMed Healthcare is seeking an experienced Cath Lab Tech for an exciting Travel Allied job in Elkhart, IN.Shift: Inquire Start Date: 07/27/2026 Duration: 13 weeks Pay: $2430.At CrossMed Healthca... Show more

 • Promoted

Travel Cath Lab Tech - $2650.8 / Week

Atlas MedStaffElkhart, IN, US
Full-time

Atlas MedStaff is seeking an experienced Cath Lab Tech for an exciting Travel Allied job in Elkhart, IN.Shift: 4x10 hr days Start Date: ASAP Duration: 13 weeks Pay: $2650.Atlas Medstaff is currentl... Show more

 • Promoted

Quality Supervisor

Southwire CompanyBremen, IN, United States
Full-time

A leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers.Southwire and its subsidiaries manufacture building wire and cable, utility ... Show more

 • Promoted

Manufacturing (Quality) Engineer

Legrand NAWarsaw, IN, United States
Full-time

Position DescriptionAt a GlanceLegrand has an exciting opportunity for aManufacturing (Quality) Engineerto join theAudio Video Divisionin Warsaw, IN.Manufacturing (Quality) Engineer will plan, and ... Show more

 • Promoted

Quality Auditor

LippertGoshen, IN, United States
Full-time

OverviewWho We Are:Lippert is a leading, global manufacturer and supplier of highly engineered products and customized solutions, dedicated to shaping, growing and bettering the RV, marine, automot... Show more