Job Description

A fantastic opportunity has arisen for a Senior Technical 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.

Our facility in Dunboyne 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.

What you will do:

Bring energy, knowledge, innovation to carry out the following:

• 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 actively to cover compliance topics.
• Facilitate daily cross-functional run the business tier meetings.
• Leading 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
• manufacturing documentation preparations/approvals.
• Trouble shooting, leading/ completing investigations, proposing/implementing Corrective and Preventative Actions.
• Lead Change controls and Quality Docs as appropriate.
• Participate and comply with the Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant. Contribute for driving a culture of Continuous Improvement within Operation
• 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 complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Brining in appropriate stakeholders when required.
• 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.

What skills you will need:

In order to excel in this role, you will more than likely have:

• 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.
• Familiarity with contamination control and batch release requirements
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
• Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits
• Proficiency in various SingleUse techniques and experiences in the area of an end to end Single Use facility.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please do not hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/3/2025

*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.