Job Description
An amazing opportunity has arisen for a Support Operations Associate 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: Assist team members within the Production and Support Operations teamParticipate daily on cross-functional teams to collaboratively cover compliance topics.Participate in cross-functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments, and Process improvement projects.Support developmental and clinical commercial supply activities such as manufacturing documentation preparations/approvals.Troubleshoot, lead/complete investigations, and propose/implement Corrective and Preventative Actions.Author 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 Operation.Monitor operational performance and follow-up on any significant adverse trends for the identification and implementation of operational optimization and robustness improvement projects.Solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve, and develop.Act as a Change and QRA Champion within the organization and site to bring about new technologies, digitization, and identify opportunities for new ways of working.Assist new members of staff in specific plant activities when required and act as a key point of contact for external groups.Conduct all work activities with 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/WIs.Required Education, Experience, and Skills: Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.2+ years of experience in the Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
Position level will scale with experience level of candidate.Competent in analyzing complex situations and demonstrating practical problem-solving capabilities.Ability to work independently and within a cross-functional team.Familiarity with contamination control and batch release requirements.Experience in supporting Regulatory Inspections and Site Internal Audits.Preferred Experience and Skills: Deviation and CAPA authoring.Experience in 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.Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully:
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position-specific.
Please, no phone calls or emails.
Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 03/19/2025
*A job posting is effective until 11:59:59PM 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: R336989
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