Share this Job
Email similar jobs to meEmail similar jobs to me

Principal Validation Specialist Job

Date: Nov 22, 2017

Location: Cork, IE

Company: MSD

Requisition ID: ENG003338

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


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 Priniciple Technical 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 Priniciple Technical Specialist is accountable for supporting all technical components to deliver an effective and efficient Vaccines IPT.

Primary activities/responsibilities:


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

  • Lead and close process related deviations and reports. 

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

  • Ensure highest Quality, Compliance and Safety standards. 

  • Participate and comply with the MSD Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant. 

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

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

  • 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.

  • Author/approve Change controls and MIDAS documents as appropriate. 
Qualifications


  • 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.
Experience


  • > 5 years’ experience in a similiar role in a manufacturing environment. Ideally in a senior role.

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

  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations, with experience of successfully delivering a significant process / technical project

Skill Set



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

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

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

  • Demonstrated leadership, including change management skills with a continuous improvement focus

  • 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.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



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


Job Segment: Developer, Biotech, Engineer, Pharmaceutical, CAPA, Technology, Science, Engineering, Management