Job Description
An amazing opportunity has arisen for a Senior BioProcess Associate – (DS Downstream) to join our Drug Substance team at our state-of-the-art, fully integrated vaccine facility in Dundalk Ireland. As a Senior 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.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
* Manufacturing SME in DS unit operations: Clarification, intermediate purification, UFDF, Buffer preparation.
* Work with the manufacturing team in executing those tasks in a safe, compliant, and efficient manner to maintain production schedules.
* Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records (paper and electronic).
* 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
* Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.
* Support the development of training matrices and ensuring compliance to training requirements.
* 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.
* Perform initial troubleshooting of issues identified during routine operations.
* Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times.
* 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.
* Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, and team training.
* 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.
What skills you will need:
In order to excel in this role, you will more than likely have:
* 2+ years experience in biopharmaceutical manufacturing with experience in downstream processing.
* Experience in operating a drug substance pilot plant and/or a commercial facility.
* Expertise and specific experience in UF/DF unit operations.
* Equipment experiences in Single use Mixers, Integrity tester, BSC, Tubing Pump, Tubing Welder.
* Ability to positively influence and work well with others.
* Ability to troubleshoot with tools such as 5 whys & Fishbone, DMAIC.
* Comfortable making risk-based decisions.
* Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.
* Previous experience acting as designee to the shift lead role is advantageous.
* Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are complied with is advantageous. Self-motivated with excellent communication and interpersonal skills.
* High level of adaptability working in a fast-paced environment and champion change.
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.
Required Skills:
Aseptic Operations, Aseptic Operations, Biopharmaceutical Industry, Biopharmaceuticals, Cleanroom Gowning, Computer Literacy, Driving Continuous Improvement, Environmental Regulations, Fast-Paced Environments, GMP Compliance, GMP Documentation, GMP Training, Manufacturing Processes, Master Batch Records, Pharmaceutical Manufacturing, Process Management, Process Manufacturing, Production Management, Production Operations, Production Scheduling, Regulatory Compliance, Risk Assessments, Safety Compliance, Standard Operating Procedure (SOP) Writing, Teamwork {+ 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:
02/17/2026
*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.