Process Support Coach Job

Date: Mar 7, 2019

Location: Carlow, IE

Apply now »
Apply now

Apply for Job

Requisition ID: MAN005838

Manufacturing Process Support Coach
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



The Manufacturing Process Support Coach is:



  • Responsible for review and approval processes for the Integrated Process Team (IPT) GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and reliable supply to our customers.

  • Support manufacturing activities through oversight and management of equipment and process investigations associated with non-GMP activities and completion of quality notifications. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.

  • Support Batch release through ensuring timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements. Ensure all manufacturing incidents are appropriately investigated in a timely manner with adequate CAPA development to prevent recurrence.

  • Leadership activities including selection, development, coaching and day to day management of the Process Support Specialists.

  • Manage Customer and supplier complaint investigations associated with manufacturing activities ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.


POSITION RESPONSIBILITIES
You are:



  • Required to comply with our 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.


  • Collaborate with Technical and Quality Departments to ensure robust investigation of quality events. Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.

  • Partner with manufacturing shift coaches and colleagues to deliver communications, training, project work, audit/inspection duties etc.; thereby ensuring department is audit/inspection ready.

  • Drive effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is subsequently carried out in line with same.

  • Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.

  • Drive compliance with our 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

  • Work collaboratively to drive a safe and compliant culture in Carlow.



REPORTING STRUCTURE

Will report to the Associate Director Operations


*Featured

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

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

3-5 years experience in a leadership role GMP setting with 1-2 years experience in investigation of quality events desirable, ideally background in manufacturing, process engineering or quality.

Technical
Strong knowledge of GMP processes including investigation of quality events and implementation of CAPA’s to prevent recurrence. Working knowledge of problem solving and risk assessment methodologies such as 5 whys, Fishbone, FMEA, QRM

People
• Demonstrated ability to coach and lead a team.
• Strong focus on delivery and results driven.

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, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Engineer, Oncology, CAPA, Pharmaceutical, Law, Engineering, Healthcare, Management, Science, Legal

Apply now »
Apply now

Apply for Job