BioProcess Associate

Bio Process Associate page is loaded## Bio Process Associate remote type:
Not Applicable locations:
IRL - Louth County - Dundalktime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
February 3, 2026 (14 days left to apply) job requisition :
R381006

Job Description We are looking 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.
** 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:

** Biological Manufacturing, Biopharmaceuticals, Good Manufacturing Practices (GMP), Operations Management, Pharmaceutical Manufacturing, Process Manufacturing, Production Operations, Shift Work, Standard Operating Procedure (SOP) Writing, Vaccine Production
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
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