Ecocareers · 3 months ago
Manufacturing Process Validation Engineer
El Paso, TX
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expConfidential company is seeking a Manufacturing Process Validation Engineer for their state-of-the-art facility in El Paso, Texas. The role focuses on leading manufacturing process validation activities to achieve departmental and plant goals, with responsibilities including developing and executing validation protocols and coordinating supplier support for custom equipment.
Staffing & Recruiting
Responsibilities
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 cGMP's, Quality Standards, and established policies and procedures
Executes other duties assigned by his supervisor
Qualification
Required
Bachelor's 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)
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
Requires a MS or bachelor's degree in engineering or related field with 10+ years of experience in an engineering role
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase