Manufacturing Process Validation Engineer

Medical Devices Manufacturing Process Validation

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 Complying with cGMP's, Quality Standards, and established policies and procedures
• Support on Executing other duties assigned by his Process Validation Lead & other supervisors

Qualifications Knowledge and

Skills:

• 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
• 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 bachelor's 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.