Validation Engineer jobs in Saint Louis, MO

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Validation Engineer
  • Sim Surgical
  • FENTON, MO FULL_TIME
  • The Validation Engineer at Sim Surgical will be instrumental in ensuring our devices meet all regulatory standards and company requirements. This role will design, execute, and document validation processes to support the development and manufacturing of products such as spinal implants, medical screws, and surgical tools. The role will be critical in maintaining our commitment to delivering safe, reliable, and high-quality medical devices that improve patient outcomes.

    Responsibilities:
    • Develop and implement validation plans for new and existing products, considering design, manufacturing processes, equipment, and software in compliance with FDA regulations and ISO standards.
    • Coordinate with Engineering, manufacturing, and quality teams to establish requirements and standards for validation activities.
    • Execute validation tests including but not limited to design validation, process validation, software validation, and test method validation.
    • Prepare, review, and approve validation documents, including protocols, reports, and risk assessments.
    • Ensure that all validation activities are conducted in accordance with internal procedures and regulatory requirements.
    • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
    • Provide technical support for troubleshooting and resolving validation issues encountered during production or testing.
    • Stay current with industry standards, regulatory requirements, and advancements in technology and apply them to validation practices.
    • Collaborate with cross-functional teams to facilitate changes or improvements in manufacturing processes, product design, and quality assurance methods.
    • Assist in the development and implementation of training programs related to validation processes and procedures.

            Requirements:
    • Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
    • Minimum of 3 years of experience in validation engineering within the medical device industry.
    • In-depth knowledge of FDA regulations, including QSR and ISO 13485, as well as other international standards relevant to medical device manufacturing.
    • Strong understanding of validation principles, including design, process, and software validation.
    • Experience with statistical analysis tools and methodologies.
    • Excellent problem-solving, analytical, and organizational skills.
    • Strong communication and teamwork skills, with the ability to work effectively in cross-functional teams.
    • Ability to manage multiple projects simultaneously and meet deadlines.

            Physical Requirements:
                    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
     
    • Moderate noise levels typical of a manufacturing setting.
    • Regular requirement to sit, talk, and hear.
    • Frequent need to walk; use hands for fine manipulation, handle objects, and reach.
    • Occasional requirement to stand, climb, balance, stoop, kneel, crouch, or crawl.
    • Occasionally lift and/or move objects up to 25 pounds.
    • Increased time spent in an office setting for data analysis, meetings, and administrative tasks.
    • Frequent use of computers and office equipment.
    • Potential travel to other company locations, suppliers, customers, or industry events.
  • 26 Days Ago

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Verification and Validation Engineer
  • bioMérieux
  • Hazelwood, MO FULL_TIME
  • Position Summary: Develop, support, and implement verification and validation activities through mentorship in the writing, execution, and summarization of verification and validation plans and protoc...
  • Just Posted

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Verification and Validation Engineer
  • bioMerieux Inc.
  • Hazelwood, MO FULL_TIME
  • Verification and Validation Engineer Location: Hazelwood, MO, United States Position Type: Unfixed Term Job Function: Engineering Share: A family-owned company, bioMerieux has grown to become a world ...
  • Just Posted

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Software Validation Engineer
  • bioMérieux
  • Hazelwood, MO FULL_TIME
  • Position Summary:As a Software Validation Engineer, you will oversee and support implementation of software lifecycle deliverables such as validation, change management and decommissioning, review/app...
  • 1 Month Ago

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Method Validation Engineer HPLC and LC/MS
  • Compliance Team
  • St. Louis, MO FULL_TIME
  • Overview Compliance Team, LLC. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, ...
  • 1 Month Ago

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Validation Specialist
  • Virbac Corporation
  • Bridgeton, MO FULL_TIME
  • Experiencing together a unique human adventure Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individ...
  • 26 Days Ago

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0 Validation Engineer jobs found in Saint Louis, MO area

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Mechanical Engineer
  • Dsj Global
  • Saint Louis, MO
  • Mechanical Engineer Job Responsibilities: Lead the design, development, and testing of innovative products tailored for ...
  • 4/25/2024 12:00:00 AM

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Technical Sales Engineer (RFID/Bluetooth- Contract/Remote- 50% Travel)
  • Optomi
  • St. Louis, MO
  • Technical Sales Engineer- RFID/BLE- 50% Travel Optomi, in partner with an industry leader, is seeking an experienced Tec...
  • 4/25/2024 12:00:00 AM

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RS Aircraft Technician Sr A&P - St Louis MO
  • Hiring Now!
  • Saint Louis, MO
  • RS Aircraft Technician Sr A&P - St Louis MOin GAC St. Louis Unique Skills: Candidates must be able to work any shift, as...
  • 4/25/2024 12:00:00 AM

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Installation Lead
  • Avik Services, LLC
  • Saint Louis, MO
  • Job Description Job Description ***There is no local office but does require travel to client sites, when you are not tr...
  • 4/22/2024 12:00:00 AM

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Vessel Chief Engineer
  • American Commercial Lines LLC
  • Saint Louis, MO
  • Job Title: Vessel Chief Engineer Company: American Commercial Barge Line Location: Memphis, TN; St Louis, MO; Cairo, IL;...
  • 4/22/2024 12:00:00 AM

I
6D2CI2-Engr Technical Specialist 2 - 6AB-Engr Technical Specialist-General
  • Indotronix International Corporation
  • Saint Louis, MO
  • Indotronix is seeking a Onsite Job - Government Property Management Specialist for a Job Opportunity in Berkeley, Missou...
  • 4/21/2024 12:00:00 AM

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6B1BI3-Design and Analysis Engineer 3 - 660-EE Sys Design Engineer-General
  • Indotronix International Corporation
  • Saint Louis, MO
  • Indotronix is seeking a 100% Onsite Job - Design and Analysis Engineer 3 for a Job Opportunity in Saint Louis,Missouri C...
  • 4/21/2024 12:00:00 AM

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Associate Plant Engineer
  • Metropolitan St. Louis Sewer District
  • Saint Louis, MO
  • Job Description FOR THIS POSITION ONLY: We are seeking an engineer to work in our Wastewater Treatment Plants or Pump St...
  • 4/21/2024 12:00:00 AM

St. Louis (/seɪnt ˈluːɪs/) is an independent city and major inland port in the U.S. state of Missouri. It is situated along the western bank of the Mississippi River, which marks Missouri's border with Illinois. The Missouri River merges with the Mississippi River just north of the city. These two rivers combined form the fourth longest river system in the world. The city had an estimated 2017 population of 308,626 and is the cultural and economic center of the St. Louis metropolitan area (home to nearly 3,000,000 people), which is the largest metropolitan area in Missouri, the second-largest ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$54,698 to $73,065
Saint Louis, Missouri area prices
were up 0.7% from a year ago

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