Clean Utilities Engineer Job

Date: Feb 11, 2019

Location: Cork, IE

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Requisition ID: PRO017494

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 BRINNY


 


MSD Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis.


 


The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand.


 


Purpose of Role:
The purpose of this role is to be a clean utilities Engineer supporting the Sterile Integrated Process Team. This is a key role to ensure that the day to day operations of the Utilities provided to the IPT are compliant.

Activities Within Role:



  • Support audits on clean utility systems.

  • Be responsible for adherence to site and corporate QMS for clean Utility Systems

  • 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.

  • Review and approve Utility & HVAC modifications, change requests, and SOP’s.

  • Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan

  • Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.

  • The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems).

  • Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.

  • Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.

  • Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.

 


Continuous Improvements:
Use Lean principles to deliver a cost efficient operating model for commercial production while not compromising EHS and Quality standards.

Coaching and Training:
Coaching others by sharing your skill-set and expertise. Identifying talent and coaching and nurturing them to develop and perform at their maximum potential.

Reports to:
Compliance Engineering Manager.


 


*Featured


*Engineering

Qualifications


Job Experience:



  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment.


Qualifications



  • Degree or 3rd Level Qualification (Engineering), Masters preferred.

  • Desirable to have qualification in Reliability Engineering and/or Project Management.

  • Bachelor of Engineering in a related discipline.


Skill-Set Expected:



  • Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS & GMP)

  • Very Strong Leadership Skills

  • Technical knowledge

  • Ability to respond to competing priorities

  • Communications skills

  • Problem solving skills

  • Ability to prepare budgets and tightly control expenditures

  • Relevant experience in pharmaceutical production management.

  • Very strong knowledge of industrial safety standards. 

  • Beneficial to have previous operational knowledge within Drug Product, Drug Substance or Utilities.

  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing or Quality etc.)

  • Knowledge and experience in applying Six Sigma and Lean Methodologies.

  • Demonstrated leadership and change management skills with a continuous improvement focus.

  • Proven experience in reducing energy consumption through innovative technology and lean thinking.

  • Demonstrated understanding of Project life Cycle , from design through to commissioning/qualification & retirement

  • Strong talent developer, proven capability of fostering engineering/technical talent

  • Beneficial to have strong networks within Engineering/Technical community

  • Customer Focus – proven ability to delight customers & end users.


Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Oncology, Utility, Biotech, Pharmaceutical, Environmental Health & Safety, Healthcare, Energy, Science

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