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 Summary for Manufacturing Process Validation Engineer (Entry Level) El Paso TX
- Assist in coordinating and supporting suppliers for manufacturing custom equipment/tooling
- Assist in purchasing delivery and installation of equipment/tooling
- Support development and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols and reports
- Support development and execution of test method validations and Gage R&R studies
- Help generate and issue SOPs (Standard Operating Procedures) and manufacturing procedures for approval
- Support development and execution of component qualifications
- Support development and execution of PQ (Performance Qualification) and PPQ (Process Performance Qualification) protocols and reports
- Assist in manufacturing capacity analysis
- Support process characterizations and Design of Experiments (DOE) activities
- Assist in creating documentation and justification for assigned capital projects
- Ensure compliance with cGMPs quality standards and established policies and procedures
- Perform other duties as assigned by Process Validation Lead or supervisors
Qualifications:
- Bachelors degree in engineering (required)
- Minimum 3 years of experience in an engineering role (or MS with at least 2 years)
- Experience in medical device manufacturing process validation preferred
- Strong written and verbal communication skills in English and Spanish
- Knowledge of IQ/OQ/PQ test method validation Gage R&R DOE manufacturing line/capacity analysis equipment/tooling design SOP generation and root cause analysis
Other Skills:
- Experience with equipment installation and preventive maintenance procedures
- Familiarity with product financials and supply chain design
- OEE integration vertical startup and zero-loss mindset
- Assist in coordinating and supporting suppliers for manufacturing custom equipment/tooling
- Assist in purchasing delivery and installation of equipment/tooling
- Support development and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols and reports
- Support development and execution of test method validations and Gage R&R studies
- Help generate and issue SOPs (Standard Operating Procedures) and manufacturing procedures for approval
- Support development and execution of component qualifications
- Support development and execution of PQ (Performance Qualification) and PPQ (Process Performance Qualification) protocols and reports
- Assist in manufacturing capacity analysis
- Support process characterizations and Design of Experiments (DOE) activities
- Assist in creating documentation and justification for assigned capital projects
- Ensure compliance with cGMPs quality standards and established policies and procedures
- Perform other duties as assigned by Process Validation Lead or supervisors
Qualifications:
- Bachelors degree in engineering (required)
- Minimum 3 years of experience in an engineering role (or MS with at least 2 years)
- Experience in medical device manufacturing process validation preferred
- Strong written and verbal communication skills in English and Spanish
- Knowledge of IQ/OQ/PQ test method validation Gage R&R DOE manufacturing line/capacity analysis equipment/tooling design SOP generation and root cause analysis
Other Skills:
- Experience with equipment installation and preventive maintenance procedures
- Familiarity with product financials and supply chain design
- OEE integration vertical startup and zero-loss mindset
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
