Carlow Start up 2 - Technical Engineering Associate Director Job

Date: Jan 11, 2019

Location: Carlow, IE

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Requisition ID: MAN005759


MSDC Technical Engineering Associate Director

Carlow

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 CARLOW

MSD in Carlow is a world-class manufacturing facility, and the company’s first stand-alone vaccine and biologics facility outside the US. Carlow employs over 350 highly skilled employees and is an important element of MSD’s network of sites, playing a pivotal role in the manufacture of our immuno-oncology treatment.
MSD Carlow is a state-of-the-art, 200,000 sq ft vaccines and biologics facility focused on formulating and filling vaccine and biologic products that improve and transform the lives of people across the world.
MSD’s sustained investment in Ireland empowers Carlow to offer its team the opportunity to continuously grow, learn, invent and thrive. We are growing our highly-skilled team and building our presence in Carlow so that we can continue to lead scientific breakthroughs in the treatment of some of the world’s most harmful diseases.

MSD recently announced that it is to construct a second manufacturing facility at its existing site in Carlow with the creation of 150 new jobs. The new facility called MSDC will focus on the production of vaccines and biologics. The site will also see the expansion of its warehouse and laboratory services.

& SPECIFIC OBJECTIVES



  • The Technical Engineering lead MSDC will play a leadership role in the development of MSD Carlow 2 drug product facility.

  • The Technical Engineering Lead MSDC will lead and manage a cross disciplined group of process, validation, project engineers, managed services and SME’s to deliver on the Technical Engineering activities needed to support the design, construction, commissioning, qualification, approval and operation of the Carlow 2 drug product manufacturing facility. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration.

  • Ensure that objectives are effectively achieved, consistent with MSD's requirements to ensure compliance, safety and reliable supply to our customers.

  • As a core member of the MSDC leadership team, The Technical Engineering Lead MSDC will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable MSD standards for Quality and EHS compliance.


POSITION RESPONSIBILITIES



  • Leadership activities including selection, development, coaching and day to day management of the Technical Engineering Team whilst delivering to the site business needs.
    Ensure that the team receives appropriate resources and programmes to develop both technical and people skills, to complete their activities whilst stimulating personal growth and development in line with role. Develop and maintain training programmes. 
     

  • To plan & agree strategies and manage technical transfers and the associated process development activities through to PPQ and commercial manufacture.

  • To plan and manage process engineering and validation activities to support the start-up and commercial operation of the Carlow 2 facility. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning cycle development & validation, PCM, CTU mapping and filter validation.

  • The Technical Engineering Lead MSDC will partner with site Technical Operations to ensure alignment with existing systems established at the site and seamless integration of Carlow 2 into the site Technical Operations structure on completion of the Carlow 2 project.

  • Sponsor and foster lean six sigma and standard work within the technical engineering value stream Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making). Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.

  • Ensure compliance with MSD Global Policies, Procedures and Guidelines,
    regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions,

  • May be required to perform other duties as assigned.

  • Expected travel – 10%


REPORTING STRUCTURE

Carlow 2 Facility Lead




*HJCarlow

Qualifications


QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General



  • Process engineering and/or validation experience in a aseptic manufacturing environment and a proven track record in leading a technical team of engineers / scientists in support of operations and technical transfer projects.

  • Experience with facility commissioning and startup an advantage.

  • Proven track-record in delivering results in a world-class supply organisation.

  • A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.

  • Innovative thinker, with excellent decision-making and problem-solving skills.

  • Experience of working in a cross functional environment.

  • Demonstrated leadership with at least 5 years’ experience in a people management role.

  • Knowledge of and experience in applying Six Sigma and Lean methodologies.

  • Positive, flexible action-oriented attitude.

  • Evidence of continuous professional development is desirable.


Technical


 



  • Experience in sterile filling processes and aseptic manufacturing.

  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices

  • In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing

  • Experience of executing and/or managing through equipment and process validation in a sterile environment

  • Good shipping/Filter/Cleaning validation knowledge required

  • Knowledge of QbD/CPV desirable

  • Excellent report, standards, policy writing skills required

  • Recruitment and selection experience

  • Automation and MES knowledge

  • Proficiency in Microsoft Office and job related computer applications required

  • Lean Six Sigma Methodology experience desired

  • Experience in audit preparation and execution desired

  • Having a strong safety ethos

  • Have proven record of process improvement implementation


People



  • The passion to expand the future of Carlow.

  • Ability to participate in and lead highly-effective teams.

  • The desire to continuously learn, improve and develop.

  • A great communicator, decisive decision-maker with a proven ability to deliver excellence

  • Strong leadership and interpersonal skills.

  • Willingness to support the team and a strong focus on delivering excellence.

  • High personal integrity, credibility, energy and flexibility.

  • Model the MSD leadership behaviours and use the MPS principles to achieve project success.

  • Build diverse talent with the capabilities necessary to succeed in commercial vaccine manufacture; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.

  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. 

  • Focus on Customers and Patients

  • Collaborate on site and within the MSD network

  • Drive Results & accountability within the team

  • Strive to be innovative in how we do business

  • Engage with our business colleagues and learn from them as well as from our own experiences

Education



  • Degree qualification or equivalent (Science, Engineering, Technical).

  • Green Belt Preferable

Why is this a compelling position for a dynamic and ambitious leader in aseptic manufacturing to consider?



  • This is a hugely exciting opportunity for an ambitious and experienced individual to play a key role in a dynamic, motivated, high-performing group at an exciting moment for MSD’s expansion in Ireland.

  • The role is a chance to shape the development of a state-of-the-art facility and holds future opportunities for advancement.

  • The candidate will be actively supported and encouraged to continue their professional development.

  • This Technical Engineering Lead MSDC role at MSD Carlow Site offers opportunities to progress in the company’s growing Irish operation and across MSD’s Global Operations.



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: Manuf./Operations Generic
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, Manager, Engineer, Construction, Pharmaceutical, Healthcare, Management, Engineering, Science

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