This role will be part of Manufacturing Self Directed work team/ Hub in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists.

The role is responsible for all procedures and processes associated with the manufacture of Drug Substance at MSD Dunboyne manufacturing facility, at the highest standards of Safety, Quality and Compliance.

The role will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include the execution of an automated recipe using paperless technology in order to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state of the art single use technology based facility. The incumbent will be involved in setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles.

Primary responsibilities include but not limited to:

• Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.
• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
• Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
• Routinely talk about any safety issues you are concerned about.
• Work as part of a dedicated proess team where flexibility and teamwork are a key requirement.
• Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
• Adhere to Right First-Time principles.
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• Escalate issues as appropriate to manager/designee.
• 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.

What skills you will need:

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

• Minimum of a Level 7 qualification in a science or engineering discipline. Or A level 6 with a minimum of 2 years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.
• Demonstrated successes in a team environment in either a project or work-related activities.
• Demonstrated troubleshooting competency.
• Broad Understanding of Bioprocessing operations is desirable.
• Good understanding of GMP requirements in a Biopharmaceutical Facility.
• Ability to interact with multiple stakeholders across numerous departments
• Excellent communication skills and the ability to work in a cross functional collaborative environment.
• Good “Can do attitude” with an ability multi-task and prioritise as appropriate.
• Good interpersonal skills, attentiveness, and an approachable manner for interactions with inter-departmental colleagues.
• High degree of problem-solving ability and adherence to scheduled timelines

Reports to: BioNX Operations Production Manager

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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R213688