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Principal Validation Engineer
2 months ago
The Role:
Our client, a world-renowned medical device manufacturer, is looking for a Principal Validation Engineer for their growing team in Cleveland, MS.
Must Haves:
- BS degree required. (Engineering, Computer Science or other Science Field)
- 3 years or more minimum related experience.
- Experience with Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project preferred.
- Basic knowledge of manufacturing processes and the ability to quickly learn and understand processes/applications.
- ASQ Certification (CQE or CSQE) or equivalent desired.
Responsibilities:
- Preform equipment qualification, test method and process validation activities, process capability and process control studies for assigned areas.
- Plan and implement software validation activities in manufacturing and support areas.
- Drive quality/manufacturing projects applying Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
- Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.
- Lead process improvement projects including automation and computerization.
- Ensure computer systems and applications are aligned with regulatory quality standards through validation activities.
- Responsible for ensuring FDA regulations are met for system upgrades/replacements.
- Responsible for audits, creation, and implementation of Specifications/SOPs.
- Responsible for ensuring the quality of facility systems (validation):
- Writing and implementing protocols and test cases for validations.
On Offer:
- 4 Weeks PTO
- Relocation Assistance
- 401K Match
- Employee Stock Purchase Program
- Paid Parental Leave
- Medical, Dental and Vision
- Tuition Reimbursement
***NO C2C