Spclst, Operations

Job Description

A fantastic opportunity has arisen for a Manufacturing Technical Operations Specialist.

This role will be part of our Manufacturing Technical Excellence 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 Manufacturing Technical Operations Specialist 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.

The Manufacturing Tech Operations Specialist 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.

• 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.

• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.

• Ensure supply of high-quality product through equipment availability.

• Provide technical, process and engineering expertise within a wide range of projects within the IPT.

• 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 escalate in a timely fashion.

• Act as a key point of contact for the introduction of new process equipment into the facility, and provide technical support for the operations based manufacturing personnel as equipment is brought on line.

• Have an in depth 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.

• 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.

• Adhere to Right First-Time principles.

• Maximize team member performance through continuous process improvement initiatives.

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

• Minimum Level 7 qualification in Science, Engineering or related discipline.

• 3-5 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.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

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.

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 don't 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.

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

Current Employees apply HERE

Current Contingent Workers apply HERE