Validation Engineer

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description 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. Requirements: 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. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr