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Validation Engineer Biomedical Jobs in Indiana (NOW HIRING)

Trimedx

Biomedical Technician IIl

Lafayette, IN · On-site

Valid driver's license required; variable travel requirements depending on primary site that may ... Bachelor's degree in engineering technology preferred * Technical Certification (CBET) preferred

Noblesoft Technologies

CNC MFG Engineer

Warsaw, IN · On-site

$70K - $89K/yr

Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline. * Experience: 3-7 years in CNC manufacturing and equipment validation in a ...

TRIMEDX Holdings

Biomedical Technician I

Muncie, IN · On-site

$23.50 - $31/hr

... engineering environment preferred Valid drivers license required; variable travel requirements depending on primary site that may require use of personal vehicle Knowledge Complex computer skills ...

New

Trimedx

Biomedical Technician Il

Lafayette, IN · On-site

$24.25 - $32.25/hr

Valid driver's license required; variable travel requirements depending on primary site that may ... Minimum 3 years' experience working with biomedical equipment in a clinical engineering environment

TRIMEDX Holdings

Biomedical Technician Il

Lafayette, IN · On-site

$24.25 - $32.25/hr

Valid driver's license required; variable travel requirements depending on primary site that may ... Minimum 3 years' experience working with biomedical equipment in a clinical engineering environment

AMARIS GROUP SA

Development Engineer

Warsaw, IN · On-site

$60 - $85/hr

Support preliminary product evaluations, design verification, design validation, and process ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering ...

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Validation Engineer Biomedical information

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are popular job titles related to Validation Engineer Biomedical jobs in Indiana?

For Validation Engineer Biomedical jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Indiana look for?

The top searched job categories for Validation Engineer Biomedical jobs in Indiana are:

What cities in Indiana are hiring for Validation Engineer Biomedical jobs?

Cities in Indiana with the most Validation Engineer Biomedical job openings:

Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in Indiana as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

CQV Engineer - Commissioning, Qualification & Validation

Process Automation - Controls.Instruments.Validations, Inc.

Indianapolis, IN • On-site

$70 - $90/hr

Other

Medical, Retirement, PTO

Posted 17 days ago

Key responsibilities

  • Support the commissioning, qualification, and validation of manufacturing systems, equipment, facilities, utilities, and automation systems within regulated pharmaceutical environments.

  • Develop and complete validation deliverables such as validation plans, risk assessments, project strategies, user requirements, functional and design specifications, impact assessments, traceability matrices, test cases, engineering studies, and final reports.

  • Participate in project review meetings, perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), and support change management activities related to design updates, deviations, and testing outcomes.

Job description

CQV Engineer (Commissioning, Qualification & Validation)

Location: Indianapolis, IN
Travel: Up to 40% domestic & international travel

Bring Critical Manufacturing Systems to Life

We bring advanced manufacturing to life by delivering world‑class automation, validation, and instrumentation solutions. Our teams solve complex challenges, support industry‑leading facilities, and make a measurable impact on critical manufacturing operations every day.

We are looking for a CQV Engineer to join our Indianapolis, IN team. In this position, you will support the commissioning, qualification, and validation of manufacturing systems, equipment, facilities, utilities, and automation systems within regulated pharmaceutical environments. You will work on high‑impact capital projects that help transform complex systems into operational, compliant, and production‑ready assets.

Responsibilities
  • Develop and drive completion of Commissioning & Qualification (C&Q) deliverables, including validation plans, risk assessments, project strategies, user requirements, functional specifications, design specifications, impact assessments, traceability matrices, test cases, engineering studies, and final summary reports.
  • Apply a strong understanding of commissioning and qualification principles to support project execution and regulatory compliance activities.
  • Support pharmaceutical capital projects for:
    • Active pharmaceutical ingredient (API) manufacturing equipment
    • Filling operations
    • Device assembly systems
    • Packaging equipment
    • Facilities and utilities
    • Automation systems
  • Participate in project review meetings, including design reviews, qualification reviews, testing strategy discussions, execution reviews, and project status meetings.
  • Develop, review, and maintain validation and qualification documentation within electronic lifecycle management systems.
  • Assess, document, and support change management activities resulting from design updates, deviations, and testing outcomes.
  • Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.
  • Complete required client training and site‑specific onboarding requirements.
  • Perform other duties as assigned.
Qualifications
  • Bachelor's degree in Biomedical or Chemical Engineering.
  • Experience with Commissioning & Qualification (C&Q) deliverables, CQV activities, validation documentation, or relevant academic/project experience.
  • Strong understanding of validation principles and deliverables, including requirements development, design, testing, and reporting.
  • Strong interpersonal, verbal, written, and presentation communication skills.
  • Highly motivated, results‑driven mindset with the ability to manage multiple priorities in a fast‑paced environment.
  • Demonstrated project management skills and the ability to independently drive assignments to completion.
  • Ability to travel up to 40% domestically and internationally.
Why Join PACIV
  • Work on pharmaceutical manufacturing and life sciences capital projects.
  • Gain hands‑on experience with commissioning, qualification, validation, FAT, and SAT activities.
  • Collaborate with experienced engineering, automation, and validation professionals.
  • Build expertise working with manufacturing systems, utilities, facilities, and automation technologies.
  • Contribute to projects that support critical manufacturing operations and production readiness.
Compensation & Benefits
  • Generous Paid Time Off: Vacation, Sick Leave, and Company Holidays
  • PACIV pays 90% of yearly health care premiums
  • Health Savings Account (HSA) with Company Contributions
  • 401(k) with Company Match up to 4% and immediate vesting with enrollment

Equal Opportunity Employer

PACIV is an Equal Opportunity Employer and considers all qualified applicants in accordance with applicable federal, state, and local employment laws. Employment is contingent upon successful completion of applicable pre‑employment requirements and verification of authorization to work in the United States.

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