Job Description
An amazing opportunity has arisen for a Support Operations Specialist 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.
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
Bring your energy, knowledge, and innovation to:
* Lead/Guide team members within the Production and Support Operations team
* Coach and develop colleagues within the Production and Support teams
* Lead, facilitate and participate daily on cross-functional teams to collaboratively cover compliance topics.
* Leading and participating in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments and Process improvement projects.
* Supporting developmental clinical commercial supply activities such as:
o Manufacturing documentation preparations/approvals.
o Troubleshooting, leading/completing investigations, proposing/implementing Corrective and Preventative Actions.
* Author/approve Change controls and Quality Docs as appropriate.
* Participate and comply with the Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant. Contribute to driving a culture of Continuous Improvement within Operations.
* 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.
* 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 analyzing complex situations and show practical problem-solving capabilities.
* Ability to work independently and within a cross-functional team.
* Familiarity with contamination control and batch release requirements.
* Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits.
Preferred Experience and Skills:
* Deviation and CAPA ownership and authoring.
* Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions.
* Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
* Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.
Employee Status: Regular
Relocation: Not Applicable
VISA Sponsorship: Not Applicable
Travel Requirements: Not Applicable
Shift: Not Applicable
Valid Driving License: Not Applicable
Hazardous Material(s): Not Applicable
Job Posting End Date: 03/19/2025
A job posting is effective until 11:59:59 PM 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.
Requisition ID: R336991
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