Shire Senior Calibration Engineer in Dunboyne, Ireland

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

Responsibilities

TECHNICAL CALIBRATION SERVICING

  • 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.

OPERATIONAL AND TECHNICAL SUPPORT

  • 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.

PROJECT SUPPORT

  • Execute calibration projects and improvement initiatives by following a systematic approach in accordance with financial and business requirements.

  • Accountable for the design, establishment and execution of calibration projects.

  • Ensure that the calibration program is appropriately structured, resourced and staff trained to meet plant goals and objectives and ensure that improvement projects are delivered.

  • Provide appropriate technical input to ensure plant and equipment design, commissioning, qualification and validation is executed per site calibration requirements.

SYSTEMS CALIBRATION

  • Collaborate with Manufacturing, Facilities, Process Development, Automation, Quality Assurance, EHS, Global Engineering, Validations and Maintenance teams in developing requirements and recommendations for calibration enhancements, changes and improvements.

  • Utilise Operational Excellence tools and techniques in completing investigation and implementing technical solutions to resolve complex problems.

  • Establish and maintain best-in-class plant calibration, process and methodologies around the management of instruments and plant equipment in accordance with cGMP and GEP’s.

Education & Experience Requirements

Essential :

  • A minimum of a Bachelor’s degree or Diploma in Metrology or Instrumentation or equivalent.

  • At least 8 years’ industrial experience, with at least 5 years in pharmaceutical manufacturing, medical devices or equivalent.

  • Must have knowledge of Metrology concepts, including accuracy, precision and uncertainty. Must be able to deal with complex processes.

Desired:

  • A relevant postgraduate qualification in validation, engineering, automation or TPM is desirable.

  • Operational Excellence/ Lean Six Sigma qualification or competency in leading, training and/or implementing root cause analysis and effective investigation practices.

  • A background of working in advanced automated manufacturing operations with integrated sophisticated processes.

Key Skills and Competencies

  • Excellent interpersonal and influencing skills.

  • Proven ability around identifying and eliminating inefficiencies and implementing innovative technological solutions.

  • Proactive at keeping current with the latest technologies and calibration practices.

  • A team player prepared to lead, work in and embrace an interdependent working culture.

  • Ability to lead teams and medium size projects.

  • Must have proficient knowledge of CMMS and automated calibration management systems.

  • Can read and understands P&IDs and advanced understanding of instrumentation, process and controls.

  • Understand PLC and digital based control systems and their instrumentation interfaces.

  • Demonstrate judgments and initiative in problem resolution underpinned by a solid grasp of data and problem solving tools.

  • Priority setting to complete priority tasks on time.

  • Strong professional writing skills.

  • Strong assessment and troubleshooting skills.

  • Ability to prepare and present technical reports, plans and schedules without assistance.

  • Must be able to put our patients at the centre of everything we do.

  • Able to operate with agility and a learning mind-set so that we can accelerate breakthrough innovations.

  • Must be able to thrive in diverse high performing teams.

  • Able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.

  • Living our leadership behaviours is a basic expectation for all Shire employees.

  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be An Excellent Manager of Self and Others

  • Provides direction, guidance and technical support to internal/external stakeholders to ensure excellence around collaboration and the creation of an interdependent operating culture.

  • Role model behaviours that creates a culture of respect and dignity in line with the Shire Guide for ethical conduct.

  • Strengthening the overall engineering leadership and organisational capabilities.

  • Enterprise mindset to ensure the right prioritization for the site.

  • Excellent influencing/collaboration skills and teamwork mind-set.

  • Demonstrated trouble shooting and problem solving skills.

Other Job Components

Complexity and Problem Solving

  • Familiar and capable of using a range of Lean Six Sigma/ OPEX and troubleshooting tools i.e. RCA, DMAIC, FMEA and Fishbone analysis.

Internal and External Contacts

  • Build partnerships with the Global Biologics Engineering Leadership Team and Global Calibrations Centre of Excellence Lead to create and sustain a culture that demonstrates excellence and sets the benchmark in calibration, continuous improvement and current best practices.

  • Execute selection and manages service contractors and suppliers to ensure effective services, competency level, cost, and compliance with Shire requirements.

  • For safety and quality, the individual is accountable to drive a culture of ‘everyone owns safety and quality’ with input from the Quality and EHS Leads.

  • Collaborates with the internal and external technical forums to ensure delivery of the objectives, best practices and business excellence.

Other Requirements

  • Ability to work in fast-paced dynamic environment and handle multiple tasks simultaneously.

  • Limit travel 5% required.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.