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Senior Validation Engineer

Senior Validation Engineer

EPM ScientificBoston, MA, US
4 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Title : Senior Validation Engineer

Location : Boston, MA (on-site)

About the Role :

A growing biotech company working on regenerative medicine is looking for a Senior Validation Engineer to join their team. If you're experienced in GMP environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit. You'll be helping make sure everything runs smoothly and meets regulatory standards.

What You'll Be Doing :

  • Handling IQ / OQ / PQ for equipment, facilities, cleaning, sterilization, and manufacturing processes.
  • Writing and executing validation protocols, project plans, and final reports.
  • Coordinating with different teams to keep projects on track.
  • Updating and creating SOPs when needed.
  • Leading technical tasks and helping hit project milestones.
  • Supporting investigations, CAPAs, and equipment release.
  • Pitching in with calibration and metrology work.
  • Mentoring junior engineers and sharing your expertise.
  • Jumping in on other quality-related tasks as needed.

Requirements :

  • Bachelor's in engineering or science with 6+ years of validation experience, or a Master's with 4+ years.
  • Solid background in GMP validation-equipment, processes, utilities, or software.
  • Experience with temperature chambers, sterilization, cleaning, and depyrogenation.
  • Familiarity with GE Kaye Validator or Ellab systems.
  • Must be authorized to work in the US without visa sponsorship

    • Please apply directly in for more information!

    Company Description

    A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.

    Job Responsibilities :

  • \tConducting Post Market Activities and Post Market Surveillance
  • \tManaging Customer and Product Complaint Investigation programs

    • Education and Experience :

  • \t1 YR. of experience in a technical role in the medical device / pharma / biotech industry
  • \tBachelor's degree
  • \tComputer proficiency

    • Company Description

    A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities : \r\n

  • \tConducting Post Market Activities and Post Market Surveillance\r\n
  • \tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience : \r\n
  • \t1 YR. of experience in a technical role in the medical device / pharma / biotech industry\r\n
  • \tBachelor's degree\r\n
  • \tComputer proficiency
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