MANUFACTURING TECHNOLOGIST, UPSTREAM/DOWNSTREAM Job

Date: Nov 24, 2018

Location: Dublin, IE

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Requisition ID: MAN005696

MANUFACTURING TECHNOLOGIST, UPSTREAM/DOWNSTREAM
MSD 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.

Ours MSD Biotech facility in Dublin is now seeking experienced Manufacturing Technologists in both Upstream and Downstream Commercial large-scale Drug Substance manufacture.
This is a great opportunity to join during a start-up phase where you can develop that in-depth knowledge that only a start-up will afford you.



& SPECIFIC OBJECTIVES



  • The Manufacturing Technologist is a key technical SME role with responsibility to ensure MSD Biotech facility is operationally ready for commercial large-scale production of Drug Substance as per start-up schedule.

  • The Manufacturing Technologist will lead, execute and support operational projects to ensure start up milestones are met.

  • The Manufacturing Technologist will operate to the highest standards of Safety, Quality and Compliance.


POSITION RESPONSIBILITIES



  • Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the MSD, Biotech manufacturing facility.

  • Support Equipment Design/ HAZOP and Room programming reviews as per requirements.

  • Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.

  • As Manufacturing Technologist, you will work with the Integrated Process Team (IPT)to ensure the effective and efficient on-time delivery of batch production within the IPT area. This requires the delivery of process excellence and reliability across all areas of the IPT.

  • Protocol/report authoring/execution/oversight/approval as appropriate

  • Support Generation of SOPS/Electronic Batch Records for start-up and facilitate review workshops as deemed necessary.

  • Participate and comply with the MSD Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.

  • Provide ongoing coaching and support to cross functional team members, to share process, engineering and maintenance best practices.

  • Provide coaching and development to all technicians within the IPT.

  • Tactical Implementation & Support for reliability equipment initiatives.

  • Ensure supply of high-quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.

  • Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and processes.

  • Author/approve Change controls and MIDAS documents as appropriate


REPORTING STRUCTURE

The Manufacturing Technologist will report to the Associate Director, Process Support Operations.

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General



  • Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, etc.

  • Demonstrated problem solving capabilities

  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.

Technical



  • A minimum of 8 years’ experience in a highly regulated GMP Manufacturing Environment.

  • 5 years’ experience in a highly regulated pharmaceutical manufacturing environment in a technical or manufacturing support role.

  • Start-up experience in a large-scale commercial drug substance facility highly desirable.

  • In depth knowledge of Upstream/Downstream processes is essential.

People



  • Ability to interact with multiple stakeholders across numerous departments

  • ability to work independently and as part of a team.

  • excellent communication skills and the ability to work in a cross functional collaborative environment.

  • People management skills desirable.

 


Education



  • Minimum of a Level 7 qualification in a science or engineering discipline.


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 


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


 



*HJFeatured
*HJDublin



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


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