Validation Engineer

• 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:

• Bachelor’s 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

The expected salary range for this position is between $52,500 to $94,500 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.