- Location
- IRL - Meath - Dunboyne, Ireland
- Type
- Full-time
- Department
- Operations
- Closing date
- Today
- Source
- Workday
Description
Job Description
This role will be part of our Manufacturing Technical Operations Team as a rotational Operations Graduate 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 Operations Graduate 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 Operations Graduate 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.
Responsibilities:
- 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.
Education & Experience:
- Recent graduate 2:1 in a Science, Engineering or related discipline.
- 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.
PQ20
Required Skills:
Ability to Coordinate, Ability to Coordinate, Chemical Engineering, Commercial Operations Management, Conflict Management, Continuous Improvement Techniques, Cross-Functional Project Management, Data Analysis, Engineering Design, Engineering Standards, Engineering Support, Estimation and Planning, Industrial Engineering, Manufacturing, Manufacturing Equipment, Manufacturing Processes, Manufacturing Scale-Up, Manufacturing Strategies, Problem Solving, Process Alignment, Process Design, Process Implementations, Process Improvements, Product Delivery, Production System {+ 9 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:
Project Temps (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
09/19/2026*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.