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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Process Operations Specialist


Reference:AS23487 Location: Meath
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing and Technology Manager, Manufacturing Coordinator, Manufacturing Executive

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.support end-to end production operations for both Fed Batch and Continuous Manufacturing.

Duties:

  • 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.
Education and Experience:
  • Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
  • 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). 
  • 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.
  • 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. 
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.