Manufacturing Process Validation Engineer

Omni Inclusive

Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements. Good Manufacturing Practices (GMP).

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 Compling 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.

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Vacancy posted 5 days ago

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