What are the responsibilities and job description for the Metrology Support Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities and Requirements : Responsible for the calibration, maintenance, and validation of equipment and instruments used in the biotechnology manufacturing and research processes. This role ensures all instruments meet stringent industry standards and regulatory requirements, playing a critical part in maintaining product quality and compliance. Perform regular calibration of laboratory and manufacturing instruments, including but not limited to, pipettes, balances, temperature sensors, and spectrophotometers. Develop and maintain calibration schedules to ensure timely calibration of all equipment. Troubleshoot and repair instruments as needed to minimize downtime. Conduct validation activities for new equipment and systems to ensure they meet required specifications and regulatory standards. Prepare and review validation protocols and reports, ensuring documentation is complete and accurate. Ensure all calibration and validation activities comply with industry standards (e.g., ISO 17025, GMP) and regulatory requirements (e.g., FDA, EMA). Maintain accurate and detailed records of calibration and validation activities for audit purposes. Generate and maintain standard operating procedures (SOPs) related to metrology processes. Prepare reports summarizing calibration and validation results, highlighting any issues or deviations. Train and support laboratory and manufacturing staff on proper use and maintenance of instruments. Provide technical support to resolve instrument-related issues. Bachelor's degree in engineering, Metrology, Biotechnology, or a related field. Minimum of 3-5 years of experience in a metrology or quality assurance role within the biotech or pharmaceutical industry. Experience with GMP, ISO 17025, and other relevant standards.
