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
- Assist in coordinating and supporting suppliers for manufacturing custom equipment/tooling
- Assist in purchasing delivery and installation of equipment/tooling
- Support development and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols and reports
- Support development and execution of test method validations and Gage R&R studies
- Help generate and issue SOPs (Standard Operating Procedures) and manufacturing procedures for approval
- Support development and execution of component qualifications
- Support development and execution of PQ (Performance Qualification) and PPQ (Process Performance Qualification) protocols and reports
- Assist in manufacturing capacity analysis
- Support process characterizations and Design of Experiments (DOE) activities
- Assist in creating documentation and justification for assigned capital projects
- Ensure compliance with cGMPs quality standards and established policies and procedures
- Perform other duties as assigned by Process Validation Lead or supervisors
Qualifications:
- Bachelors degree in engineering (required)
- Minimum 3 years of experience in an engineering role (or MS with at least 2 years)
- Experience in medical device manufacturing process validation preferred
- Strong written and verbal communication skills in English and Spanish
- Knowledge of IQ/OQ/PQ test method validation Gage R&R DOE manufacturing line/capacity analysis equipment/tooling design SOP generation and root cause analysis
Other Skills:
- Experience with equipment installation and preventive maintenance procedures
- Familiarity with product financials and supply chain design
- OEE integration vertical startup and zero-loss mindset
Employment Type
Full-time
