Validation Engineer
Validation Engineer
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1 Vacancy
Job Description
Job Title: Validation Engineer
Location: North Haven CT (Onsite)
Job Description:
- As a Validation Engineer within the Mold & Capital Tooling Organization youll play a pivotal role on a global enterprise team collaborating with various sites around the world.
- In this role youll facilitate or perform critical validation & qualification activities ensuring the seamless release of high-quality injection molded components that drive our mission forward.
- Ensure proper qualification and validation of suppliers and their processes ensuring supplier meets the requirements for producing high-quality reliable products.
- Developing and executing validation plans conducting audits and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
- Write review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures standard calibration methods standard test methods specifications CAPAs and exception reports.
- Strong documentation skills Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
- Review test results and measurements to identify discrepancies.
- SPC (Statistical Process Control)
- Knowledge on ISO 13485 FDA GMP ISO 14971 FDA CFR 820
- Clean Room experience and medical prod mfg exp (added advantage).
- Communicates with stakeholders obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
Qualification:
- Bachelors degree with a minimum of 5-7 years of experience in a regulated environment OR an advanced degree with a minimum of 3 years of experience.
- Minimum of 5 years of professional experience in a relevant field
- Experience with Agile PLM and SAP or BPCS ERP systems
- Experience with CAD model with use of Solidworks or AutoCAD
- Experience with NPI and design transfers deliverables for injection molded components
- Experience within highly regulated industry
- Hands on experience within production and enterprise environment
Employment Type
Full-time
