Validation Specialist
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Validation Specialist with a strong knowledge of injection molding processes to support the development execution and documentation of validation activities (Protocols Tests Reports).
- Familiarized with IQ OQ and PQ validation phases for molds and equipment.
- IQ: Confirmation of Drawings (including mold attributes) Equipment and Procedures (mold setup and operating) mechanical assessment of mold and equipment.
- Develop inspection programs and instructions for setup/positioning of tooling and parts.
- Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
- Updating and defining Standard Operating Procedures (SOPs).
- Familiarized with Gage R&R methodology preferable.
- Preferably familiarized with metrology equipment and methods such as calipers micrometers CMM Programmable Vision Inspections Systems.
Requirements
- Bachelor in Science
- Experience in FDA regulated industry
- 5 years of experience performing validation lifecycle activities
- Techical writting skills
- Read write speak and understand English and Spanish
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
