Tech, Operations

Job Description

A fantastic and exciting opportunity has arisen for a Senior Manufacturing Biotech Associate.

This role will involve working shift, on a 24/7 basis. This role is a site based position.

The Senior Manufacturing BioTech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement

Key responsibilities for a Senior Manufacturing Biotech Associate. include executing automated recipes using paperless technology to manufacture drug substance.

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

• The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing.
• Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
• Conduct all work activities with a strict adherence to the safety and compliance culture onsite.
• Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques.
• Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.

What skills you will need:

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

• Level 7 qualification in a science or engineering discipline desired.
• A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing environment shall be deemed equivalent.
• Competent in troubleshooting and show practical problem-solving capabilities.
• Ability to work independently and within a cross-functional team.
• Familiarity with contamination control and batch release requirements.
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
• Experience with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
• Experience in various Single-Use techniques and experiences in the area of an end to end Single Use facility.

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 inclusive, 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.

So, if you are ready to:

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

Required Skills:

Analytical Thinking, Analytical Thinking, Applied Engineering, Business Administration, Business Information Systems, Business Systems, Cleanroom Gowning, Computer Literacy, Engineering Mathematics, Equipment Set Up, Fabrication Processes, GMP Compliance, GMP Environments, GMP Operations, Good Manufacturing Practices (GMP), In-Process Control (IPC), Manufacturing Environments, Mechatronics, Organizational Compliance, Pharmacy Regulation, Problem Resolution, Production Processes, Production Scheduling, Recordkeeping, Standard Operating Procedure (SOP) Management {+ 2 more}

Preferred Skills:

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:

06/20/2026

*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.