Quality Validation Engineer

4 weeks ago

Horsham, United States Medix™ Full time

We are looking for an experienced Validation Engineer to join our exciting and rapidly growing biotech client. Interested applicants must be local to the area and have equipment, method, and process validation experience.


Overview: The Quality Validation Engineer serves as the primary specialist resource for development, execution, review, and approval of a variety of equipment and processes that are critical to the quality systems, production environment and laboratory spaces for the company. Primary responsibilities cover validation and FDA-compliance related documents/protocols for equipment qualification, (including laboratory equipment), process validation, test method Validation and related change controls to assure compliance with cGMPs in a medical device environment.


Responsibilities:

  • Author, review, execute and approve technical documentation, plans, protocols, and reports. This includes but is not limited to Equipment Qualification, Process Validation, Test Method Validation, related change controls, and SOPs for IVD and RUO products. Computer System Validation experience is helpful but not essential.
  • Supports equipment qualification and requalification: laboratory instruments/systems, processing equipment, temperature controlled equipment, etc.
  • Lead and Participate in quality- and process improvement initiatives and projects.
  • Stays current with changes to GMP, including FDA, EU, ISO, and other regulatory bodies as well as guidance documents related to validation.
  • Interact frequently with Laboratories, Manufacturing, QC and Facilities to provide expertise on equipment qualification and validation. Address conditions/practices with appropriate personnel; report findings to executive management as necessary.
  • Works on routine assignments per written procedures; ability to recognize deviation from accepted practice.
  • Participates and supports specific safety and quality responsibilities for department and site (i.e., GMP, Audits, Environment, and Health & Safety).
  • Works and collaborates cross-functionally, primarily with R&D/Product Support, Industrial Operations, QC and Facilities.
  • Manages and coordinates the use of third parties for the Installation and operational qualification of new equipment/Instruments/systems.
  • Maintain the Validation Master Plan (VMP).
  • Participates in cross-functional design, development and investigative activities (root cause analysis) especially in support of validation and qualification activities.
  • Support and actively participate in third party audit and regulatory inspection activities

Requirements:

  • Bachelor’s degree in a scientific or engineering (BioMedical, Mechanical Chemical Engineering etc), Biotechnology or Pharmaceutical Science, Quality Assurance, Manufacturing or similar is ideal.
  • Minimum 3+ years’ experience in a GMP, FDA, and ISO regulated environment.
  • Previous quality engineering experience / managing qualification and validation activities

  • Validation Quality Engineer

    1 week ago

    Horsham, Pennsylvania, United States Medix™ Full time

    Medix™ is seeking a skilled Validation Quality Engineer to become a vital part of our dynamic and expanding biotech organization. Candidates should possess substantial experience in equipment, method, and process validation.Position Overview: The Quality Assurance Validation Specialist acts as the key expert for the development, execution, review, and...

  • Quality Validation Engineer

    4 days ago

    horsham, United States Medix™ Full time

    We are looking for an experienced Validation Engineer to join our exciting and rapidly growing biotech client. Interested applicants must be local to the area and have equipment, method, and process validation experience.Overview: The Quality Validation Engineer serves as the primary specialist resource for development, execution, review, and approval of a...

  • Quality Validation Engineer

    4 weeks ago

    Horsham, United States Medix™ Full time

    We are looking for an experienced Validation Engineer to join our exciting and rapidly growing biotech client. Interested applicants must be local to the area and have equipment, method, and process validation experience.Overview: The Quality Validation Engineer serves as the primary specialist resource for development, execution, review, and approval of a...

  • Quality Validation Engineer

    2 days ago

    horsham, United States Medix™ Full time

    We are looking for an experienced Validation Engineer to join our exciting and rapidly growing biotech client. Interested applicants must be local to the area and have equipment, method, and process validation experience.Overview: The Quality Validation Engineer serves as the primary specialist resource for development, execution, review, and approval of a...

  • Quality Assurance Validation Specialist

    1 week ago

    Horsham, Pennsylvania, United States Medix™ Full time

    Medix™ is seeking a skilled Validation Quality Engineer to enhance our dynamic and expanding biotech organization. Candidates should possess substantial experience in equipment, method, and process validation.Position Overview: The Quality Assurance Validation Specialist is the key expert responsible for the development, execution, review, and approval of...

  • Aerospace Quality Assurance Engineer

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Quality Control Engineer - Avo PhotonicsAvo Photonics stands at the forefront of contract engineering services, focusing on tailored opto-electronic solutions across diverse sectors. We are in search of a meticulous Quality Control Engineer to enhance our aerospace quality framework. The successful candidate will play a pivotal role in ensuring adherence to...

  • Aerospace Quality Engineer

    3 months ago

    Horsham, United States Avo Photonics Full time

    Avo Photonics ( is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and communications.We seek a...

  • Aerospace Quality Engineer

    4 days ago

    horsham, United States Avo Photonics Full time

    Avo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and...

  • Aerospace Quality Engineer

    3 months ago

    Horsham, United States Avo Photonics Full time

    Avo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and...

  • Aerospace Quality Engineer

    3 months ago

    Horsham, United States Avo Photonics Full time

    Avo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to produce next generation products for a diverse range of markets including aerospace, military, medical, industrial, and...

  • Quality Assurance Specialist in Aerospace Engineering

    1 week ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Aerospace Quality Assurance Engineer - Avo PhotonicsAvo Photonics stands at the forefront of contract engineering services, focusing on tailored opto-electronic solutions across diverse sectors. We are in search of a meticulous Aerospace Quality Assurance Engineer to enhance our team and oversee our aerospace quality framework. The successful candidate will...

  • Quality Assurance Supervisor

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Avo Photonics is a leading provider of contract engineering services specializing in the design, development, and manufacturing of tailored opto-electronic solutions for a diverse clientele. Our team members engage in the creation, prototyping, and production of innovative products across various sectors, including environmental, medical, military,...

  • Quality Assurance Lead

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Avo Photonics is a progressive contract engineering services firm specializing in the design, development, and manufacturing of tailored opto-electronic solutions for a diverse clientele. Our team members are presented with the opportunity to innovate, prototype, and produce cutting-edge products across various sectors, including environmental, medical,...

  • Quality Assurance Supervisor

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Avo Photonics is a forward-thinking contract engineering services firm specializing in the design, development, and manufacturing of bespoke opto-electronic solutions for a diverse clientele. Our team members are afforded the opportunity to innovate, prototype, and produce cutting-edge products across various sectors, including environmental, medical,...

  • Quality Assurance Supervisor

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Company Overview:Avo Photonics is a progressive contract engineering services firm specializing in the design, development, and manufacturing of tailored opto-electronic solutions for a diverse clientele. Our team members engage in the creation, prototyping, and production of cutting-edge products across various sectors, including environmental, medical,...

  • Quality Assurance Supervisor

    3 days ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Avo Photonics is a vibrant contract engineering services firm specializing in the design, development, and manufacturing of tailored opto-electronic products for a diverse clientele. Our team members have the unique opportunity to innovate, prototype, and produce cutting-edge products across various sectors, including environmental, medical, military,...

  • Quality Assurance Supervisor

    1 week ago

    Horsham, Pennsylvania, United States Avo Photonics Full time

    Avo Photonics is a vibrant engineering services firm specializing in the design, development, and manufacturing of tailored opto-electronic solutions for a diverse clientele. Our team members engage in the creation, prototyping, and production of innovative products across various sectors, including environmental, medical, military, industrial, aerospace,...

  • Supplier Quality Engineer, Staff Level

    2 weeks ago

    Horsham, United States Lockheed Martin Corporation Full time

    Job ID: 669402BR Date posted: Aug. 12, 2024Description:The Work• Work in Supplier Quality Assurance capacity within an integrated program Subcontract Management Team and Quality Team environment.• Take an active role in supplier development activities, as needed, to ensure long term program success.• Collaborate with LM Program Quality, Engineering,...

  • Application Engineer Intern

    1 week ago

    Horsham, United States Schneider Electric MA Full time

    Application Engineer Intern - 75410 DESCRIPTION/RESPONSIBILITIES: Schneider Electric has an opportunity for an Appliation Engineer Intern! Join our team in the Philadelphia area and gain hands-on experience in providing engineering support for building automation and security management systems while contributing to the successful delivery of...

  • Quality Assurance Analyst

    1 month ago

    Horsham, United States Lightbeam Health Solutions Full time

    Job DescriptionJob DescriptionJOB SUMMARY:The Quality Assurance Analyst will estimate, plan, and coordinate testing (both manual and automated) activities. The engineer will also ensure that quality issues and defects are appropriately identified, documented, tracked, and resolved in our defect tracking system.JOB RESPONSIBILITIES: Analyzing business...