Job Description

An amazing opportunity has arisen for a Manufacturing Technical Operations Associate Specialist. 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 Manufacturing Technical Operations Associate 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.

What you will do:

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

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 escalate in a timely fashion. Adhere to Right First-Time principles. Maximize team member performance through continuous process improvement initiatives.

Qualifications

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

Minimum Level 7 qualification in Science, Engineering or related discipline. 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 a company, we are committed to 'Inventing for Life' in all that we do. 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 or click on the link to find out more about our hybrid working model

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/18/2025

*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:R336009