Description

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

Calibration Specialist - Shanbally, Cork
Hybrid role - minimum 3 days per week onsite

Overall purpose of the role

Reporting into the Manager, Engineering and Reliability at Shanbally, the Calibration Specialist will be expected to own and deliver the Calibration program on site while simultaneously increasing their own technical capability through training and experience as well as the capability of others. 

Responsibilities

• Responsible for coordinating, controlling and managing the calibration program for BioMarin International Ltd. Shanbally operations.
• Oversight of new instrument introduction ensuring all listed instruments are assigned appropriate calibration frequencies, testpoints and tolerances with respect to the listed criticalities & process ranges.
• Responsible for updating and maintaining calibration records in accordance with regulatory and cGMP requirements.
• Responsible for completion and input into all Quality investigations and change controls related to instrumentation on site
• Responsible for the reviewing, approving of all calibration certificates and associated documentation.
• Responsible for ensuring all procedures related to calibration program are maintained accurate and up to date.
• Provide technical support to the project team throughout project life cycles.
• Setup and review of service contracts with BioMarin Legal Representatives
• Ensure that maintenance & calibration is carried out in accordance to cGMP regulations, safety considerations and site quality standards.
• Use of permit to work system or other safety systems to control engineering activities.
• Participation in design reviews as required from an instrumentation perspective
• Ensure that all engineering documentation are maintained in compliance with relevant cGMPs and GEPs.
• Other duties as assigned.

Competencies & Skills

• Cognitive capability – Ability to learn quickly and to be able to share those learnings to wider colleagues in a way that is understandable.
• Ownership and Accountability – Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks “what can I do to help?”
• Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.  High tolerance for ambiguity and able to create order from chaos.  Builds credibility through solid relationships and solid track record of results.
• Communication - Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.  Ability to draft and deliver clear and concise procedures or business process documents.
• Planning/Organization - Excellent planning and prioritization skills with the ability to multitask and adapt.  Able to synthesize large amounts of information.  Able to deliver results despite shifting environment.
• Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.  Innovative and effective in solution development, risk mitigation, and execution.
• Minimum 10 years of experience in industry.

Education

• A relevant third level qualification in Science, Engineering or related discipline is preferred.
  
  

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.