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Contract Method Validation Jobs in Utah (NOW HIRING)

Senior Quality Engineer

Draper, UT · On-site

$37.59 - $42.59/hr

Contract Job Overview: Pay Range: $37.59hr - $42.59hr Requirement/Must Have: * Bachelor s degree in ... Lead and support equipment, process, and test method validation activities, including development ...

This is a full-time W-2 contract position. The selected candidate will interview with ASI and work ... Provide input into improving testing methodologies, validation frameworks, and operational testing ...

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Contract Method Validation information

What is the difference between Contract Method Validation vs Analytical Method Validation?

AspectContract Method ValidationAnalytical Method Validation
PurposeValidates that a contracted method meets specific requirements for a particular project or clientEnsures an analytical method is accurate, reliable, and reproducible for testing purposes
ScopeTypically project-specific, focusing on methods used under contractual agreementsBroader, covering method development, validation, and routine testing
CredentialsOften requires validation expertise, GMP knowledge, and industry-specific certificationsRequires analytical chemistry knowledge, validation experience, and relevant certifications
Work EnvironmentPharmaceutical, biotech, or manufacturing settings with client-specific projectsLaboratories performing routine testing and method development in similar industries

Contract Method Validation focuses on validating methods for specific client projects, while Analytical Method Validation ensures the overall reliability of testing methods used routinely in laboratories. Both roles require similar credentials and work in related environments, but their scope and purpose differ.

What are the most commonly searched types of Method Validation jobs in Utah?

The most popular types of Method Validation jobs in Utah are:

What cities in Utah are hiring for Contract Method Validation jobs?

Cities in Utah with the most Contract Method Validation job openings:

Senior Quality Engineer

Cynet Systems

Draper, UT • On-site

$37.59 - $42.59/hr

Other

Medical, Dental, Vision, Life, Retirement

Posted 4 days ago


Job description

We are looking for Senior Quality Engineer for our client in Draper, UT.

Job Title: Senior Quality Engineer

Job Location: Draper, UT

Job Type: Contract

Job Overview:

Pay Range: $37.59hr - $42.59hr

Requirement/Must Have:

  • Bachelor s degree in engineering required.
  • 2-4 years of experience required.
  • Demonstrated hands-on experience executing and documenting IQ, OQ, PQ, and TMV activities.
  • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality system requirements.
  • Experience conducting and documenting root cause investigations and implementing effective CAPAs.
  • Working knowledge of NCR, CAPA, change control, deviation, and risk management processes.
  • Experience with validation lifecycle management, protocol development, execution, and report generation.
  • Working knowledge of statistical analysis tools and quality methodologies, including SPC, Minitab, DOE, Gage R&R, and process capability analysis.
  • Experience with PFMEA, risk assessments, and problem-solving methodologies.
  • Proficiency in reviewing technical drawings, specifications, procedures, and validation documentation.
  • Strong technical writing and documentation skills.
  • Strong organizational skills with the ability to manage multiple priorities and projects.
  • Detail-oriented with a commitment to compliance and product quality.

Responsibilities:

  • Lead and support equipment, process, and test method validation activities, including development, execution, and approval of IQ, OQ, PQ, and TMV protocols and reports.
  • Ensure validation activities are performed in compliance with FDA, ISO 13485, GMP, and internal quality requirements.
  • Investigate product and process nonconformances and perform root cause analysis using structured problem-solving methodologies such as 5 Why, Fishbone, Fault Tree Analysis, and other quality tools.
  • Author, review, and maintain NCR, CAPA, deviation, validation, and technical documentation.
  • Facilitate CAPA investigations, identify corrective and preventive actions, and verify effectiveness of implemented solutions.
  • Support manufacturing, engineering, and supplier quality teams in resolving quality issues and reducing recurring defects.
  • Participate in risk management activities, including PFMEA reviews, risk assessments, and implementation of risk mitigation strategies.
  • Analyze quality and manufacturing data using statistical techniques to identify trends, adverse conditions, and opportunities for improvement.
  • Support internal and external audits and regulatory inspections by providing technical documentation and evidence of compliance.
  • Review and approve changes through change control processes and assess potential quality impacts to validated systems and processes.
  • Develop and revise quality procedures, work instructions, validation plans, and related quality system documentation.
  • Drive continuous improvement initiatives focused on process capability, defect reduction, compliance, and operational excellence.
  • Provide quality engineering support for new product introductions, manufacturing transfers, and process improvements.

Skills:

  • Installation Qualification (IQ).
  • Operational Qualification (OQ).
  • Performance Qualification (PQ).
  • Test Method Validation (TMV).
  • FDA 21 CFR Part 820.
  • ISO 13485.
  • Quality Management System (QMS).
  • Root Cause Analysis.
  • CAPA.
  • NCR.
  • PFMEA.
  • Statistical Process Control (SPC).
  • Minitab.
  • Design of Experiments (DOE).
  • Gage R&R.
  • Process Capability Analysis.
  • Strong verbal and written communication skills.
  • Ability to communicate effectively with stakeholders.

Qualification And Education:

  • Bachelor s degree in engineering.

Benefits
Our Benefits Include:
  • Medical, Dental, and Vision Insurance
  • 401(k) Retirement Plan
  • Health Savings Account (HSA)
  • Disability Insurance (Short-Term and Long-Term)
  • Life and AD&D Insurance
  • Paid Sick Leave (where required by applicable state or local law)
  • Supplemental Insurance Plans
  • Identity Theft Protection
  • Pet Insurance
  • Employee Wellness Programs
  • Employee Assistance Program (EAP)
  • Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

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About Cynet Systems

Sourced by ZipRecruiter

Cynet Systems Inc is a staffing and recruiting corporation nestled in Ashburn, VA, USA. Established in 2010, the company operates within the Information Technology and Services sector, specializing in providing effective workforce solutions to different business needs, including IT consulting, direct hire, and contract staffing services. Through the years, Cynet Systems has built an impressive portfolio, going beyond borders and expanding its operations internationally in Canada and India. Rooted in its core values of teamwork, leadership, and commitment, Cynet Systems helps businesses unlock their full potential by providing versatile and competent professionals that perfectly align with their needs. Fueled by their unwavering mission to deliver top-tier talent to businesses worldwide, Cynet Systems garnered various recognitions including SIA's fastest-growing staffing firms and Best Place to Work in Virginia for 2019.

Industry

It services

Company size

501 - 1,000 Employees

Headquarters location

Sterling, VA, US

Year founded

2010

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