Packaging Validation Engineer
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Name: Packaging Validation Engineer
Location: Bloomington IN
Mandatory: Medical Device Industry
JD:
Recent 4-6 years experience in Packaging Validation activities
- Hands on experience in packaging validation activities including packaging integrity shelf life and transit testing.
- Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements.
- Hands-on experience in Process validation (IQ OQ & PQ) activities.
- Lead or support complaint investigations and resolution related to packaging.
- Support engineering in product validation risk assessments product/process development and change management.
- Support and lead continuous improvement activities through leadership facilitation and collaboration
- Ensure all packaging validation activities are properly documented and controlled.
- Collaborate with QA Engineering Manufacturing and Regulatory teams to ensure packaging meets product and compliance requirements.
- Communicate effectively across departments regarding packaging validation status and issues.
- The Packaging Validation Engineer typically reports to the Quality Engineering Manager or QA Manager and works closely with manufacturing production engineering and supply chain teams.
Good documentation practice skills.
Good verbal and oral communication skills
Good Knowledge in ISO 13485 ISO 14971 FDA 21 CFR 820.
Hands on experience in Engineering change order creation in Agile
Location: Bloomington IN
Mandatory: Medical Device Industry
JD:
Recent 4-6 years experience in Packaging Validation activities
- Hands on experience in packaging validation activities including packaging integrity shelf life and transit testing.
- Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements.
- Hands-on experience in Process validation (IQ OQ & PQ) activities.
- Lead or support complaint investigations and resolution related to packaging.
- Support engineering in product validation risk assessments product/process development and change management.
- Support and lead continuous improvement activities through leadership facilitation and collaboration
- Ensure all packaging validation activities are properly documented and controlled.
- Collaborate with QA Engineering Manufacturing and Regulatory teams to ensure packaging meets product and compliance requirements.
- Communicate effectively across departments regarding packaging validation status and issues.
- The Packaging Validation Engineer typically reports to the Quality Engineering Manager or QA Manager and works closely with manufacturing production engineering and supply chain teams.
Good documentation practice skills.
Good verbal and oral communication skills
Good Knowledge in ISO 13485 ISO 14971 FDA 21 CFR 820.
Hands on experience in Engineering change order creation in Agile
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
