Manufacturing Process Validation Engineer
Manufacturing Process Validation Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 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 cGMPs Quality Standards and established policies and procedures.
- Support on Executing other duties assigned by his Process Validation Lead & other supervisors.
Requirements:
- Bachelors 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 bachelors 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.
Employment Type
Full-time
