Validation Engineer

Location: North Haven, CT, us

Company Description

• 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.