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MSD Drug Substance Process Operations Operational Excellence Snr Specialist 
Ireland 
533901978

30.06.2024

Job Description

Bring energy, knowledge, innovatiofn to carry out the following:

  • Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
  • A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
  • Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
  • Conduct work activities in a safe and compliant manner.
  • Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation).
  • Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to cover compliance topics.
  • Coordinates compliance-specific tasks within Drug Substance Process Operations and represents them in cross-group meetings such as Change Review-, Risk Assessment- Deviation-boards, GMBR boards and Audits preparations
  • Lead n investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
  • Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
  • Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.

What skills you will need:

  • Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
  • 6 years + experience in Biotech industry (bulk manufacturing of pharmaceutical or biological components).  Position level will scale with experience level of candidate.
  • Competent in analyzing complex situations and show practical problem-solving capabilities.
  • Ability to work independently and within a cross-functional team.
  • Demonstrated experience in QRM, Investigations and Problem solving
  • Familiarity with contamination control and batch release requirement
  • Experience in quality management systems such as Veeva, SAP, PAS-X etc..
  • Experience in Quality Assurance, Quality Control within the Biological and/or pharmaceutical industry.

Preferred Experience and Skills:

  • Commissioning and Qualification experience
  • Problem, Deviation, and Change Management experience
  • Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
  • Familiarity with Emerson DeltaV, SIPAT,  and the use of Automation in a manufacturing Process.
  • Familiarity with contamination control and batch release requirements

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today

Current Contingent Workers apply


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



Job Posting End Date:07/05/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.