Job Description:

A fantastic opportunity has arisen for a Bio Process Associate – to join our Drug Substance team at our state-of-the-art, fully integrated vaccine facility in Dundalk Ireland. As a Bioprocessing Associate, you will be a key member in our fast-growing, dynamic startup-working with cutting-edge technology.

Please note This position will initially operate standard office hours Monday-Friday but will transition to a 12hr day shift pattern or 4 Cycle shift pattern to support routine site operations.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

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

• Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation
• Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records .
• Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
• Write, review and revision of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions
• Training and mentoring of colleagues in SOPs, process execution and equipment operation.
• Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
• Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
• Lead and actively participate in shift handovers.
• Liaise with Shift Lead regarding issues which may arise within the production area including highlighting of operational challenges.
• Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1,) to optimize efficiency and drive the culture of Continuous Improvement (CI)
• Support HAZOP and risk assessments as per requirements.
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• Conducts all activities that are in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.
• ·Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.

What skills you will need:

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

• Demonstrated experience in Bioprocessing, Upstream or Downstream.
• Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.
• High level of adaptability working in a fast-paced environment and champion change.
• Experience with recording information in real time using electronic or manual systems.
• Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems.
• Experience of working in Grade C, D and CNC environment is an advantage.
• Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills.
• An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.

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.

So, if you are ready to:

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

Required Skills:

Biopharmaceutical Industry, Good Manufacturing Practices (GMP), Manufacturing Processes

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:

No relocation

VISA Sponsorship:

Yes

Travel Requirements:

No Travel Required:

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

05/5/2026

**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.