Manufacturing Process Validation Engineer

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

• 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.
• 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.

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