Manufacturing Process Validation Engineer
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Job Location:
El Paso, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Manufacturing Process Validation Engineer(Entry Level)
Job Position Location- El Paso TX
Job Responsibilities:
- Assist on Coordinating and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
- Assist on Coordinates purchase and delivery of Equipment/Tooling
- Assist on Coordinates installation of Equipment/Tooling
- Support on Developing and Executing IQ and OQ Protocols and Reports
- Support on Developing and Executing Test Method Validations / Gage R&R
- Support on Generating nd Issues for Approval of SOPs and Manufacturing Procedures
- Support on Developing and Executing Component Qualifications
- Support on Developing and Executing PQ and PPQ Protocols and Reports
- Support on Developing Manufacturing Capacity Analysis
- Support on Developing and Executing Process Characterizations / Design of Experiments (DOE)
- Support on Developing documentation/justification for assigned capital projects
- Support on Compling with cGMPs Quality Standards and established policies and procedures
- Support on Executing other duties assigned by his Process Validation Lead & other supervisors
Qualifications
Knowledge and Skills:
- Bachelors degree in engineering
- Experience in the Medical Device Industries with experience in the Manufacturing Process Validation
- Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels.
- Qualification / Validation (IQ/OQ/PQ)
- Test Method Validation / Gage R&R
- Process Characterization / Design of Experiments (DOE)
- Manufacturing Line Design / Capacity Analysis
- Equipment / Tooling Design
- Equipment Installation / Preventive Maintenance Procedure Generation
- Root Cause Analysis / Investigation
- SOP / Manufacturing Procedures Generation & Change Control
- Product Financials & Supply Chain Structure Design
- OEE Integration Vertical Start up and Zero-loss mindset
Required Education and Experience:
- Requires a bachelors degree in engineering or related field with minimum 3 years of experience in an engineering role OR MS with at least 2 year of experience in an engineering role
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
