Techncial Specialist (Vaccines Technical Team ) Job

Date: Mar 23, 2019

Location: Cork, IE

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Requisition ID: PRO019038

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.

& SPECIFIC OBJECTIVES


POSITION RESPONSIBILITIES

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

The Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, 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.


REPORTING STRUCTURE

• Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical activities but relating to all activities.
• Work 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, 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 Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

• > 3 years’ experience in biopharmaceutical/vaccines environment
• Experience Data Integrity would be an advantage
• Experience with assessing material changes would be an advantage



Technical
• 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


Education
• 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



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


*featured


*engineering


 


 


 


Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms 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: Yes, 5 % of the Time
Number of Openings: 15
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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