Senior Utilities Engineering Specialist / Clean Utilities SME Job

Date: Feb 12, 2019

Location: Dublin, IE

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Requisition ID: MAI000854

BIOTECH DUBLIN

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

INTRODUCTION

At MSD Ireland, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

THE COMPANY
MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.
We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.
In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.
With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

MSD BIOTECH, DUBLIN

The latest addition to the MSD Ireland family is MSD Biotech, Dublin. The site will play a pivotal role in the manufacture of MSD’s biologics-based medicines, including in the area of immuno-oncology, and will expand MSD’s current internal network of biologics drug substance manufacturing plants when full manufacturing operations begin in 2021.

MSD Biotech Dublin, will be MSD’s first ever Large-Scale Mammalian-Based Drug Substance Facility, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

This facility will be a significant supplier of drug substances for one of MSD’s key treatments and will also be critical in the future supply of new biotechnology products to its global network.

& SPECIFIC OBJECTIVES

The Senior Critical Utilites Engineer / SME will be responsible for supporting the start up of MSD Biotech Dublin and will be involved in Final Equipment Design, Installation, Commissioning Support and Qualification activities. They will be accountable for Operational Readiness tasks.The primary focus of the position is on GMP/clean utilities and operations (WFI, Clean Steam, HVAC and Process Gasses). They will act as Subject Matter Expert for assigned equipment and play a key role to ensure that the site is Safe and Compliant.



POSITION RESPONSIBILITIES

• Development, review and approval of technical information including design documents, Hazops, Safety Risk Assessments, Work Plans, Commissioning documents and CMMS data.
• Establish Equipment Criticality and apply appropriate reliability and asset management strategy based on criticality.
• Ensure compliance to all Safety, regulatory GMP and Environmental requirements.
• Working with technicians and other functions to develop Prescriptive, Predictive and Preventative maintenance program to ensure designated site equipment operate safe and reliable. Optimise work tasks, ensure spare parts, tools or other services are available when required.
• Investigate equipment failures or deviations to find root cause and implement effective Corrective and Preventative Actions.
• Coach, mentor and provide technical training to colleagues.
• Develop and manage People, Safety, Quality, Delivery and Cost KPI’s
• Support Engineering Excellence Initiatives – participate in local and corporate programs.
• Own the initiation, management and closure of change initiatives.
• Support regulatory audits on clean utility systems.
• Be responsible for adherence to site and corporate QMS for clean Utility Systems and Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses. Complete periodic reviews and other compliance documentation aligned with the site QMS.
• Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.
• Lead technical cross-functional teams and work across engineering areas to deliver robust and sustainable solutions and business processes.
• Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.
• Pursues and use new technologies and methodologies, consult with other subject matter experts and site on procedures and to ensure design solutions achieve long term business objectives and are supported by robust technical rationale.

REPORTING STRUCTURE

Will report to Associate Director Critical Utilities
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General
• 7+ years Engineering Utilities experience in a Biologics Manufacturing Site, with some experience of start up and qualification of new systems.

Technical
• Experience of Operations and Maintenance of Clean Utilities Systems ie Water, HVAC, Process Gasses.
• In-depth knowledge of regulatory requirements ability to provide solutions that reflect understanding of business objectives and cost implications.
• Knowledgeable of mechanical, electrical, control and automation systems maintenance requirements.
• Knowledge and experience of commissioning and validation of HVAC and Clean Utilities systems
• A compliance mindset for EH&S and Quality standards, regulations and practices.
• Experience of continuous improvement and optimisation techniques.

People
• Excellent organising, planning skills, and communication skills.
• Proven success working in a team environment with flexibility to react to changing business needs.
• High level of attention to detail and strong problem-solving abilities.
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Excellent communication skills and the ability to work in a cross functional collaborative environment.

Education
• A Level 8 qualification in an engineering discipline with evidence of continuous professional development.


 

So, if you are ready to:

INVENT solutions to meet unmet healthcare needs

IMPACT the future by joining MSD, one of the world’s leading healthcare companies

INSPIRE your team to reach their full potential and push the boundaries of science and technology




Job: Maintenance/Utilities
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Oncology, Engineer, Utility, Electrical, Biotech, Healthcare, Engineering, Energy, Science

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