Manufacturing Engineer
Manufacturing Engineer
Intellectt Inc
Salt Lake City, UT
See who Intellectt Inc has hired for this role
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
Responsibilities
Job Description:
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
Responsibilities
Job 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.
- 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.
- 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).
- Familiarity with EUMDR standards.
- Experience in manufacturing equipment/process validations, Test Method validation, and stability/aging validations.
- Onsite Interview
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Engineering and Information Technology -
Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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