What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Responsibilities
- As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll 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.
- 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 Solid works or AutoCAD.
- Experience with NPI and design transfers deliverables for injection moulded components.
- Experience within highly regulated industry.
- Hands on experience within production and enterprise environment.
