Job Description
An amazing opportunity has arisen for a Senior Manufacturing Technical Operations Specialist (CPA). This position will be part of the Manufacturing Hub at our new State of the Art single use Multiproduct Biotech facility in at Dunboyne Biologics. This role will be part of our Manufacturing Technical Operations Team in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. The successful candidate will support the development of the site by participating in cross functional teams to deliver all project milestone, supply, and commercialisation activities with a safety first, quality always mindset.
The role involves driving commercial operations, continuous improvements and standard work principles at the single use multi-product biotech facility by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
They will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
* Coach, support, and develop a high-performing technical support team within Downstream IPTs.
* Lead by example to drive individual and team performance aligned with site goals.
* Oversee technical planning and decision-making during facility ramp-up and ongoing operations.
* Lead cadence and capacity improvement programs to support Dunboyne's commercialisation mission.
* Drive transformational improvement initiatives across compliance, delivery, and cost, reporting to the Site Leadership Team.
* Consistently achieve key performance metrics including EHS, compliance, delivery, and budget targets.
* Manage change control and deviation processes within the manufacturing area.
* Oversee the impact of changes related to raw materials, automation, MES systems, and processing issues.
* Promote a culture of continuous improvement using Our Company Production System (MPS) toolkit.
* Collaborate seamlessly across site and global teams to foster technical excellence.
* Ensure compliance with internal Quality Management Systems and EHS requirements.
* Demonstrate strong leadership and change management capabilities with a focus on continuous improvement.
* Lead and support functional and cross-functional tier meetings and initiatives.
* Drive operational excellence to support stable processes across all commercialisation stages (pre-clinical, clinical, PPQ, and commercial).
* Generate and approve GMP documentation to meet compliance and regulatory expectations.
* Advocate for continuous improvement in yield, cycle time, and error reduction.
* Identify and contribute to major compliance initiatives to enhance site efficiency.
* Proactively resolve issues and manage risks to ensure timely achievement of project milestones.
Education & Experience:
* Minimum Level 7 qualification in Science, Engineering or related discipline.
* 5-8 years experience in a regulated pharmaceutical manufacturing environment, preferably in technical or operations roles.
* Demonstrated knowledge of continuous improvement methodologies & in-depth understanding of site level products & related processes.
* Demonstrated collaboration, negotiation & conflict resolution skills.
* Excellent communication skills (written and oral).
* Demonstrated understanding of continuous / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
* Exceptional analytical, problem solving & root-cause analysis skills.
* Ability to multi-task and handle tasks with competing priorities effectively.
* Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
* Experience with working in a multinational organisation.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Required Skills:
Accountability, Accountability, Applied Engineering, Batch Production, Business Solutions Development, Computerized Maintenance Management Systems (CMMS), Continuous Process Improvement, Decision Making, Environmental Regulatory Compliance, GMP Compliance, Good Manufacturing Practices (GMP), HVAC Design, Maintenance Management, Manufacturing Processes, Marketing, Mechanical Integrity, People Leadership, Pharmaceutical Manufacturing, Predictive Maintenance, Process Automations, Process Engineering, Process Improvements, Process Safety Management, Production Processes, Proven Commitment {+ 5 more}
Preferred Skills:
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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:
12/26/2025
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