Job Description

Job Summary
Primary Role
The Senior Calibration Engineer will design and implement the calibration programme for our new start-of-the-art- single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The role will be the Calibration Subject Matter Expert (SME) in the establishment of the calibration programme, performing maintenance, installation, troubleshooting, calibration and repair of a variety of electronic components, analytical equipment, controls and instruments for site wide laboratory and manufacturing equipment.
This is an important role at the plant within the Site Engineering organisation to help create value for our patients.
Essential Functions
+ Provide technical direction, supervision and input for standing up and operation of the calibration programme at the Dunboyne Biologics facility to meet functional and site objectives.
+ Responsible for identifying and critically assessing the calibration requirements for plant and equipment, drafting and implementing guidelines, standards and calibration procedures, setting out the calibration plans and schedules, conducting technical investigations, resolving calibration deviations, act as SME presenting at internal and external audits, developing and delivering training, and managing technical specifications and documentation.
+ Perform monitoring, trending of equipment and processes, and determine acceptability and tolerance requirements based on data analysis and specification.
+ Assist with vendor calibration support to equipment; including audits and contracted services to per site requirements.
+ Set up standards and special laboratory equipment to test, evaluate, and calibrate instruments, sensors and equipment.
+ Assist engineers in evaluation plans and procedures, to maintain precision accuracy of measuring, recording and indicating instruments and equipment.
+ Investigate failures and instruments that are out of tolerance, and determine acceptability of product and processes. Assist in the preparation of documentation of investigation findings.
+ Assists with development and implementation of technically defensible calibration procedures and new instruments being considered at the Facility.
+ Build and maintain relationships with customers with the concept that metrology is a service provider to the customer.
+ Coordinates the assigned activities and schedules of calibrations throughout the facility, including routine and non-routine work.
+ Makes scientific judgments related to instrumentation problem solving.
+ Enshrines safety, quality and operational excellence in the application calibration across site.
+ Subject Matter Expert and leader for the site calibration programme who works with cross-functional teams to ensure that there is an effective and robust calibration system developed and implemented at the site.
+ Responsible for generating of calibration documents, specifications, training programs, and for standing-up the Plant Calibration system, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
+ Ensure that calibration improvement projects are included in the capital plan.
+ Participate in the Site Operations Readiness team interfacing with the projects team to ensure that the project is delivered in accordance with the agreed scope.
+ Work with Maintenance Lead in establishing and meeting targeted site and Tech Ops objectives, ensuring department objectives are aligned, translated to all and visually managed to drive performance results.
+ Conducts performance reviews and development plans.
+ Ensure that calibration budgets are met and adjusted as needed.
+ Provide calibration and technical support to ensure stable, efficient and robust operations at the site.
+ Responsible for designing and implementing a best-in-class site calibration programme.
+ Works with the Maintenance Lead to develop an escalation plan for calibration support and designs a plan for out of hours calibration support.
+ Implement a calibration program for assets to support manufacturing and prevent unplanned downtime.
+ Execute change control for calibration activities including writing and executing change control test plans.
+ Responsible for timely updates of achievements and challenges.
+ Works collaboratively on resolving obstacles and building relationships so as to maintain a highly effective and productive work environment.
+ Execute calibration projects and improvement initiatives by following a systematic approach in accordance with financial and business requirements.
+ Accou
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