Process Engineer Job

Date: Apr 9, 2019

Location: Carlow, IE

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Requisition ID: PRO019069

MSD 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.

& SPECIFIC OBJECTIVES

Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.

POSITION RESPONSIBILITIES

• Serve as technical and/or validation support as required for manufacturing and new product introduction.
• Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment commissioning and qualification programs
• Execution of equipment/qualification validation programs; including re-qualification and re-validation
• Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports,
• Execution/development of change controls
• 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.
• Serve as technical engineering representative for internal technical group discussions and represent MSD Ireland (Carlow) at global technical forums.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of 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, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

REPORTING STRUCTURE

Detail reporting structure
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS



General
Participate on a team of engineers
Plan and execute C&Q, validation activities as required



Technical
Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting



Education
Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline



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: Process Engineering
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Process Engineer, Oncology, Manufacturing Engineer, Engineer, Pharmaceutical, Engineering, Healthcare, Science

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