Senior Validation Specialist Job

Date: Apr 30, 2019

Location: Cork, IE

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Requisition ID: ENG004435

Senior Validation Specialist



MSD Brinny



Are you ready to Invent, Impact, Inspire?



Join MSD and shape the future of healthcare in Ireland


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.



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.


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


This position will provide expert technical support to the Vaccines IPT for the Qualification, Validation and Technical activities for Vaccines IPT manufacture meeting the MSD Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan.

The Senior Validation Specialist will be required to collaborate with Capital Projects on the qualification of new facilities, utilities and equipment; manage external venders for the provision of qualification services and support the operationalization of the MSD quality standards within Vaccines IPT.

The successful candidate is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.


POSITION RESPONSIBILITIES 


  • Ensure highest Quality, Compliance and Safety standards are adhered to.

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

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

  • Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.

  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.

  • Participate in problem solving teams across all areas of the Vaccine IPT

  • Support process related deviations and reports.


REPORTING STRUCTURE 

Successful candidate will report to the Technical IPT Lead.
Qualifications


QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS 

General


  • 5 years’ experience in a regulated manufacturing environment..

  • Demonstrated knowledge in validation and other pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality, analytical)

  • Demonstrated delivery of a significant process / technical project





Technical


  • Demonstrated process qualification and validation SME background within the pharmaceutical or Biopharmaceutical industry.

  • Demonstrated capability to deliver results RFT, in a FDA / HPRA Regulated production environment.

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

  • Demonstrated ability to realize improvement initiatives.

  • Demonstrated high level of problem solving and facilitation skills.

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



People


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

  • Leadership ability including change management skills with a continuous improvement focus

  • Experienced at holding team members responsible for results.




Education


  • Hon. Degree or Masters in a Science or Engineering discipline

  • 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 


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: Engineering 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


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