An amazing opportunity has arisen for an Associate Specialist Operations. 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 commercialization activities with a safety first, quality always mindset.
The role involves driving commercial operations, continuous improvements and standard work principles by ensuring adherence to divisional policies, guidelines and regulatory requirements while working across self‑directed and hub teams to resolve issues and support quality, EHS, learning and continuous improvement.
What You Will Do
* Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response‑to questions, health authority inspection SME support, and more.
* Work with the Integrated Process Team (IPT) to ensure the effective and efficient on‑time delivery of batch production within the IPT area.
* Support operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
* Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
* Ongoing support to cross functional team members, to share process, engineering and maintenance best practices.
* Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.
* Have an understanding of specific EBRs in the facility, making technical changes are required to meet the demands of the business or in response to any requirements for process changes that may occur.
* Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.
* Support/Drive future updates to the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
* Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
* Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
* Resolve issues and identify risks and escape in a timely fashion.
* Adhere to Right First‑Time principles.
* Maximize team member performance through continuous process improvement initiatives.
What Skills You Will Need
* Minimum Level 7 qualification in Science, Engineering or related discipline.
* 1‑3 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.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 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 don't hesitate to contact the Talent Acquisition Partner assigned to this role should you need any support during our recruitment process.
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