Equipment Validation Engineer
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Job Location:
Dallas, IA - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Equipment Validation Engineer
Location: Dallas TX
Duration: Long Term
Job Overview:
We are looking for an experienced Equipment Validation Engineer to support qualification and validation activities for our client in Dallas Texas. The role involves executing validation studies for equipment utilities and facilities to ensure compliance with cGMP FDA and internal quality standards.
Key Responsibilities:
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Prepare review and execute IQ/OQ/PQ protocols for equipment and utilities.
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Perform temperature mapping and qualification of refrigerators freezers stability chambers and warehouses.
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Support facility and utility system validation including purified water compressed air HVAC and clean steam systems.
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Oversee qualification of process and cleaning equipment such as autoclaves part washers and sterilizers.
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Conduct risk assessments and define validation strategies following GAMP 5 and ASTM E2500 guidelines.
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Work closely with QA Facilities Manufacturing and Engineering teams to complete validation deliverables on time.
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Maintain validation documentation traceability matrices and summary reports.
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Participate in equipment change control and requalification activities.
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Ensure all documentation meets data integrity and GDP requirements.
Qualifications:
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Bachelors degree in Engineering Life Sciences or related field.
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2 years of experience in equipment or facility validation within a GMP-regulated environment.
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Hands-on experience with temperature mapping autoclaves cleanroom qualification and controlled temperature storage units.
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Good knowledge of 21 CFR Part 11 Annex 11 GAMP 5 and cGMP guidelines.
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Strong attention to detail documentation and communication skills.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
