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Manufacturing Engineer
intellectt Salt Lake, UT
$99k-117k (estimate)
Contractor | Business Services 2 Days Ago
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intellectt is Hiring a Manufacturing Engineer Near Salt Lake, UT

Hello
Hope you are doing well.
­­
This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at 1(732)-276-2791.
Role: Manufacturing Engineer III
Location: West Valley City, UT - 84119
Duration: 12 Months
ResponsibilitiesJob Description:
  • Conduct gap assessments against EUMDR standards.
  • Generate and execute validation plans and protocols (IQ/OQ/PQ), focusing on Test Method Validation and EUMDR Validation Remediation.
  • Provide statistical analysis to support validation reports.
  • Troubleshoot and recommend improvements for equipment/processes during validation runs.
  • Investigate and document non-conformance incidents and protocol deviations.
  • Complete Non-Conformance and CAPA investigations.
  • Collaborate with cross-functional teams including Manufacturing, Engineering, Regulatory, and Quality Assurance.
  • Ensure compliance with regulatory agencies (FDA, ISO, OSHA, EPA).
  • Compile and review technical documentation for regulatory submissions.
  • Participate in external audits (FDA, BSI, Corporate).
  • Perform additional related duties as needed.
Qualifications
  • Education: BS in Engineering (Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical) or related sciences.
  • Certifications: Lean/Six Sigma Green or Black Belt preferred.
  • Experience: 4-6 years in medical device/pharmaceutical manufacturing environment.
Skills
  • Strong knowledge of FDA, OSHA, EPA, GMP, and ISO requirements.
  • Proficient in Organizational Excellence and Lean/Six Sigma.
  • Strong project management and technical leadership.
  • Ability to develop technical documentation (Change Controls, Validation Plans, Reports, SOPs).
Preferred Experience
  • Familiarity with EUMDR standards.
  • Experience in manufacturing equipment/process validations, Test Method validation, and stability/aging validations.
Interview
  • Onsite Interview

Job Summary

JOB TYPE

Contractor

INDUSTRY

Business Services

SALARY

$99k-117k (estimate)

POST DATE

07/04/2024

EXPIRATION DATE

12/30/2024

WEBSITE

intellectt.com

HEADQUARTERS

ISELIN, NJ

SIZE

200 - 500

FOUNDED

2018

CEO

KIRAN MADALA

REVENUE

$5M - $10M

INDUSTRY

Business Services

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About intellectt

Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.

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