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:
Qualifications
Knowledge and Skills:
- 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
- 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.
Vacancy posted 2 days ago
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