MSD Drug Substance Process Operations Operational Excellence Snr Specialist 

Ireland 

533901978

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