Principal Technical Specialist - Vaccine Technical, Vaccine IPT Job

Date: Mar 30, 2019

Location: Cork, IE

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Requisition ID: PRO019263


MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 



Principal Technical Specialist -  Vaccine Technical, Vaccine IPT

[MSD Brinny]

 

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.




Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


 







& SPECIFIC OBJECTIVES





This position will coordinate the technical support to the Vaccine IPT to support the manufacturing and validation of processes for Vaccine IPT to meet the our manufacturing Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. 


 

 



POSITION RESPONSIBILITIES



 

The Principal Technical Specialist will be required to collaborate and facilitate running of activities (validation activities, technical support, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT.


This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.


 



Primary activities/responsibilities:

 



  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical activities but relating to all activities.

  • Work to coordinate and within a team to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.

  • Responsible for the technical support of manufacture in the Vaccine IPT.

  • Input into Technical planning and decisions for the Vaccine IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.

  • Lead and close process related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc).

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

  • Technical review, ownership of and approval of Global Change Management records as required.

  • Cleaning validation activities, Periodic reviews, monitoring Requalification of equipment

  • Recommend technical approaches in line with global and local standards.

  • Contribute for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools and MPS within the IPT on projects such as:  problem solving, reducing cycle time, lean principles within the new processes.

  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels

  • Participate and comply with the our manufacturing division Quality Management System (QMS) requirements, including ownership, as relevant.

  • Responsible for supporting a culture of Continuous Improvement by championing MSD Six Sigma tools within Technical Group for Vaccines IPT.

  • Model the MSD Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

 


 

 

REPORTING STRUCTURE



 

Vaccine Technical Lead – Vaccine IPT

 
Qualifications




QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS


 



Focus on Customers, Including Patients 

Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.




Collaborate

Actively listen and seek to understand differing perspectives; work together to achieve the common goals of MSD. Demonstrate Inclusion and MSD Leader behaviours




Act with Candor and Courage

Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.




Make Rapid, Disciplined Decisions

Make timely decisions at the right level with the right data, and support them once made.




Drive Results

Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Develop work relationships and influence colleagues across the value stream to achieve goals and remove barriers.




Demonstrate Ethics & Integrity

Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.




Build Talent: Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.


 

 



  •  > 5 years’ experience in biopharmaceutical/vaccines environment

  •  Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage

  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.

  • Experience in Validation activities e.g. Cleaning Validation, Requalification, Periodic Monitoring and Reviews

  • Experience Data Integrity would be an advantage

 


 

 



  • Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).  

  • Preference for Lean Six Sigma qualification or experience of application of Lean principles

  • Project management qualification such as, Project Management Professional is desirable

  • Evidence of Continuous Professional Development

  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.).

  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.

  • Demonstrated ability to realize improvement initiatives.

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

  • Demonstrated high level of problem solving and facilitation skills.

  • Advanced PC skills such as Excel, Word, PowerPoint.

  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.

  • Experience in a FDA / HPRA Regulated production environment

 


 

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


*brinny

*hj





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.




 

MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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