Operations Specialist

Darwin Rhodes

  • Dunboyne, Co Meath
  • Contract
  • Full-time
  • 2 months ago
ABOUT THE PROJECT
  • Work Location: Dunboyne, Ireland
  • Work model: On-site
  • Contract type: 11 months temporary fixed-term contract
  • Client: a global healthcare leader dedicated to improving health and well-being worldwide. The company focuses on innovative medicines, vaccines, and animal health products
Work week is 39 hrs / week each site.The only exception is Blackrock / Red Oak, where it is 37.5 hrs / week.ABOUT THE ROLEAn amazing opportunity has arisen for an Operations Specialist (P2), to provide operational support for manufacturing operations of the Company Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland.This role will involve supporting manufacturing operations on a Shift Rotation basis.Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous ManufacturingPrimary activities/responsibilities:
  • Lead/Guide team members within the Production Operations team
  • Coach and develop colleagues within the Production team
  • Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution
  • Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
  • Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
  • 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.
  • Lead complex process investigations on the production floor in support of deviation resolution.
  • 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
  • Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution
  • Conduct all work activities with a strict adherence to the safety and compliance culture on site
  • Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
  • Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks)
  • Ensure the effective use of material, equipment and personnel in producing quality products.
This is a 24/7 shift-based role requiring flexibility to work days, nights, weekends, and holidays. A 33.33% shift premium applies.ABOUT THE CANDIDATERequired Education, Experience and Skills:
  • Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
  • 4 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.
  • Understanding of multi column chromatography concepts
  • Familiarity with contamination control and batch release requirements
  • Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits
  • Problem, Deviation, and Change Management experience
Preferred Experience and Skills:
  • Commissioning and Qualification 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.

Darwin Rhodes