Operations Production Specialist (Shift)
Apply remote type Not Applicable locations IRL - Meath - Dunboyne time type Full time posted on Posted 2 Days Ago time left to apply End Date: April 30, 2025 (30+ days left to apply) job requisition id R338780
An amazing opportunity has arisen for an Operations Production Specialist (Shift role) to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland.
This is a shift role.
Our facility in Dunboyne, Co. Meath is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Our Dunboyne facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.
The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.
Our Dunboyne facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.
What you will do:
* Lead/Guide team members within the Production Operations team.
* Coach and develop colleagues within the Production team.
* Provide designee cover in the absence of the Production Manager.
* Lead, facilitate and participate daily on cross-functional teams to collaboratively cover compliance topics. Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
* 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.
* 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 weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation).
* Conduct all work activities with a strict adherence to the safety and compliance culture on site.
* Support the Authoring of electronic batch records, sampling plans, and standard operating procedures.
* Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s.
Required 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 analysing 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.
Reports to: Drug Substance Process Operations Manager
#J-18808-Ljbffr