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
Location- El Paso TX
Location- El Paso TX
Job Responsibilities:
Manufacturing Process Validation Lead for their state-of-the-art facility in El Paso Texas. Responsible for the Manufacturing Process Validation support activities toward attainment of departmental and plant goals. Primary focus is to play the Technical Leading role on Manufacturing process validation. Possesses technical responsibility for interpreting planning organizing executing coordinating and carrying out technical assignments based on diversified requirements. Ability to read write and speak in English and Spanish. Job Responsibilities: Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling Coordinates purchase and delivery of Equipment/Tooling Coordinates installation of Equipment/Tooling Develops and Executes IQ and OQ Protocols and Reports
Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval of SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Develops Manufacturing Capacity Analysis Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops documentation/justification for assigned capital projects Complies with cGMPs Quality Standards and established policies and procedures Executes other duties assigned by his supervisor 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
Key word to search Medical devices manufacturing process validation 21CFR Part 820 ISO 13485 process validation mold validation SAP process improvements. Good Manufacturing Practices (GMP).
Mandatory Skills
Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks
Written and verbal communication
skills (English and Spanish) and CFT
interaction Expert
21CFR Part 820 ISO 13485 Good
Process validation (IQ OQ PQ)
mold validation SAP process
improvements. Good Manufacturing
Practices (GMP). Expert
Medical Devices Manufacturing
Processes changes and
improvement Expert
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 MS or bachelors degree in engineering or related field with 10 years of experience in an engineering role
Develops and Executes Test Method Validations / Gage R&R Generates and Issues for Approval of SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Develops Manufacturing Capacity Analysis Develops and Executes Process Characterizations / Design of Experiments (DOE) Develops documentation/justification for assigned capital projects Complies with cGMPs Quality Standards and established policies and procedures Executes other duties assigned by his supervisor 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
Key word to search Medical devices manufacturing process validation 21CFR Part 820 ISO 13485 process validation mold validation SAP process improvements. Good Manufacturing Practices (GMP).
Mandatory Skills
Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks
Written and verbal communication
skills (English and Spanish) and CFT
interaction Expert
21CFR Part 820 ISO 13485 Good
Process validation (IQ OQ PQ)
mold validation SAP process
improvements. Good Manufacturing
Practices (GMP). Expert
Medical Devices Manufacturing
Processes changes and
improvement Expert
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 MS or bachelors degree in engineering or related field with 10 years of experience in an engineering role
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
