Manufacturing Engineer - Validation & Calibration Systems

Department: Operations
Reports to: Vice President, Operations

Responsible for maintaining an efficient and compliant calibration and revalidation system of all relevant equipment ensuring where possible no downtime. Develops and conducts various equipment calibrations or tasks of varying levels of scope and/or degree of complexity This position will be an individual contributor responsible calibration and revalidation support for the Woburn and Bedford facilities.

1. Oversees and coordinates the timely calibration and revalidation of manufacturing equipment and instruments. 2. Interface with Engineering, Manufacturing, Facilities, and Quality Assurance to address deviations form the norm, out of tolerances and potential product concerns related to maintenance, calibration, or revalidation issues, define and implement effective corrective actions and monitor post-implementation effectiveness. 3. Works with calibration and validation vendors/contractors to coordinate work. Ensures external calibration contractors complete work as required, on-time and with the correct standards. Prepare equipment for shipment when external calibration activities are required. 4. Maintain and update equipment records in accordance with quality systems requirements. 5. Ensures that all equipment files and associated databases are kept up to date as part of the calibration/revalidation program. Experience with Blue M Cal Man software preferred. 6. Generate metrics to track and trend calibration results. 7. Writes, reviews and updates calibration procedures and forms. Initiate maintenance and calibration procedure development and implementation, modify and update standard operating procedures as needed. 8. Ensures timely calibration of instrumentation and investigation of out of tolerance results. Reviews completed work and documentation for compliance to requirements. 9. Oversees implementation of the validation program. Ensures new equipment and methods are properly validated prior to implementation and critical equipment is periodically re-validated.

1. Requires a Bachelors Degree in engineering or related discipline with a minimum of 2 to 5 years related experience and 2. Demonstrated working knowledge of calibration and validation regulations, standards and guidance documents (21 CFR 820, ISO 13485, NIST, etc.) 3. Familiarity with regulated industries, FDA, ISO etc. 4. Working knowledge of cGMPs, QSRs, MDDs. 5. Strong writing and oral communication skills. 6. Ability to work independently as well as part of a functionally diverse team. 7. Ability to multi-task, steeting and meeting aggressive timelines. 8. Basic computer skills (e.g. Microsoft Word, Excel, Pwoerpoint, Visio, Outlook, etc) 9. Detailed oriented.