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Medical Device Validation Engineer Jobs in Indiana

Siri InfoSolutions Inc

Manufacturing Engineer

Warsaw, IN · On-site

$70K - $90K/yr

Medical Device Manufacturing Engineer Location: Warsaw, IN Duration: 6+ months Experience Required ... Experience supporting medical device manufacturing Process Validations Specific experience with ...

Lancesoft

Reliability Engineer II - Exempt

Warsaw, IN · On-site

$40 - $45/hr

Must Have * 1-3 years of experience in the Medical Device industry. * Familiarity with FDA 21 CFR ... Nice to Have * 5 years in validation of automated cells, Installation, Operational, and Performance ...

Intersurgical

Be Seen First

Account Executive - Medical Device Sales

Indianapolis, IN · On-site

$85K - $160K/yr

Join a Global Leader in Medical Device Manufacturing At Intersurgical Inc. , we're dedicated to ... Maintain a valid passport for occasional international travel. * Manage travel expenses responsibly.

New

BSI Group

Conduct comprehensive in-depth medical device reviews (including sterilization validation). Make ... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ...

Imh

Execution of newly formed service lines, including implementation and validation of new design ... Python Programing Experience * Quality Assurance and Risk Analysis. * Medical Device design ...

BSI Prof Serv EHS West

Conduct comprehensive in-depth medical device reviews (including sterilization validation). Make ... engineer for asterile medical device manufacturer * Bachelor's degree (or higher) in Microbiology ...

avalign

Sr. Design Quality Engineer

Schaumburg, IL

... process validations to support new product development. * Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products. * Ensure required design ...

Intellectt INC

Validation Specialist

Indianapolis, IN · On-site

I am reaching out regarding an exciting opportunity for a Validation Specialist position with one of our prestigious medical device clients. We are seeking professionals with experience in GMP ...

Guidehouse

Model Validation Lead

Indianapolis, IN

You will work closely with data scientists, MLOps engineers, system owners, risk stakeholders, and ... Medical, Rx, Dental & Vision Insurance * Personal and Family Sick Time & Company Paid Holidays

Guidehouse

Model Validation Lead

Indianapolis, IN

You will work closely with data scientists, MLOps engineers, system owners, risk stakeholders, and ... Medical, Rx, Dental & Vision Insurance * Personal and Family Sick Time & Company Paid Holidays

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Medical Device Validation Engineer information

What are some common challenges faced by Medical Device Validation Engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What does a Medical Device Validation Engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can reach or exceed a $500,000 annual salary, especially with experience, advanced skills, and leadership roles. Medical Device Validation Engineers typically earn less, but senior-level professionals with extensive expertise and certifications may approach high six-figure incomes in certain industries or companies.

How much does a validation engineer make at Pfizer?

A validation engineer at Pfizer typically earns between $70,000 and $100,000 annually, depending on experience, location, and certifications. Salaries may also include benefits such as health insurance and bonuses, with some roles requiring knowledge of validation protocols and regulatory standards.

Are validation engineers in demand?

Validation engineers, including those in the medical device industry, are in high demand due to strict regulatory requirements and the need for quality assurance. Their skills in validation protocols, risk management, and compliance with standards like ISO 13485 and FDA regulations make them valuable in manufacturing and quality assurance roles across healthcare and biotech sectors.

Do validation engineers make good money?

Validation engineers, including those in the medical device industry, typically earn competitive salaries that vary based on experience, location, and certifications. They often require knowledge of regulatory standards and validation tools, which can influence compensation levels. Overall, validation engineering is considered a well-paying profession within engineering fields.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are the key skills and qualifications needed to thrive as a Medical Device Validation Engineer, and why are they important?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.
What are popular job titles related to Medical Device Validation Engineer jobs in Indiana? For Medical Device Validation Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Medical Device Validation Engineer jobs in Indiana look for? The top searched job categories for Medical Device Validation Engineer jobs in Indiana are:
What cities in Indiana are hiring for Medical Device Validation Engineer jobs? Cities in Indiana with the most Medical Device Validation Engineer job openings:
Medical Device Validation Engineer jobs near you

Senior CQV Engineer/Manager

IT Minds LLC

Indianapolis, IN • On-site

Other

This job post has expired today. Applications are no longer accepted.

Job description

Job Title: Senior CQV Engineer/Manager

Location: Remote / Hybrid / Onsite (Depending on Project Requirements)

Duration: Long-Term Contract

Position Overview

We are seeking an experienced CQV (Commissioning, Qualification & Validation) professional to support and lead validation activities within highly regulated pharmaceutical, biotechnology, and life sciences environments. This role will be responsible for ensuring GMP compliance across facilities, utilities, equipment, manufacturing processes, and computerized systems while driving validation strategies and project execution.

Key Responsibilities

  • Lead and support Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, equipment, laboratory systems, and manufacturing processes.
  • Develop and execute Validation Master Plans (VMPs), risk assessments, traceability matrices, and validation protocols.
  • Author, review, and approve IQ/OQ/PQ protocols and validation summary reports.
  • Coordinate commissioning and qualification activities for cleanrooms, HVAC systems, water systems (PW/WFI), clean steam, compressed gases, and manufacturing equipment.
  • Support FAT, SAT, startup, and operational readiness activities.
  • Manage deviations, investigations, CAPAs, and change controls.
  • Ensure compliance with FDA, EMA, MHRA, GAMP 5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
  • Collaborate with Engineering, Manufacturing, Quality Assurance, Automation, Regulatory Affairs, and Validation teams.
  • Support regulatory inspections, audits, and remediation activities.
  • Provide leadership and mentoring to validation engineers and CQV team members.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
  • 10+ years of CQV / Validation experience within pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Strong experience with GMP, cGMP, and regulatory compliance requirements.
  • Extensive hands-on experience with:
    • Commissioning, Qualification & Validation (CQV)
    • IQ / OQ / PQ Execution
    • Validation Master Plans (VMP)
    • Risk Assessments
    • Traceability Matrix Development
    • Deviation, CAPA, and Change Control Management
    • GMP Documentation and Compliance

Technical Experience Required

  • Cleanroom Qualification
  • HVAC Qualification
  • Water Systems (PW/WFI)
  • Clean Steam Systems
  • Compressed Air/Gas Systems
  • Manufacturing Equipment Qualification
  • Packaging Equipment Validation
  • Laboratory Equipment Qualification
  • Process Validation

Computer System Validation (CSV)

Experience validating one or more of the following systems:

  • MES
  • LIMS
  • Empower
  • TrackWise
  • Veeva
  • SAP
  • DeltaV
  • SCADA Systems
  • Laboratory Informatics Systems

Preferred Experience

  • Pharmaceutical or Biotechnology Manufacturing
  • Cell & Gene Therapy
  • Biologics Manufacturing
  • Vaccine Manufacturing
  • Greenfield Facility Startups
  • Large Capital Projects
  • Regulatory Inspection Readiness

Preferred Certifications

  • PMP
  • CQV / Validation Certifications
  • ASQ Certifications (CQE/CQA)
  • ISPE Training
  • Lean Six Sigma Green Belt or Black Belt

Must-Have Skills

  • CQV (Commissioning, Qualification & Validation)
  • GMP / cGMP Compliance
  • IQ/OQ/PQ
  • Validation Master Plans (VMP)
  • Risk Assessments
  • Traceability Matrix
  • CAPA & Deviation Management
  • Cleanroom / HVAC Qualification
  • Utilities Qualification (PW/WFI/Clean Steam)
  • Computer System Validation (CSV)
  • FDA / EMA / GAMP 5 Compliance

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |

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