Bioprocess Associate, Formulation

Job DescriptionAn opportunity has arisen for a Formulation Bio-Process Associate based at our Dundalk site manufacturing a life changing medicine utilising the latest technology.You will be part of a multiskilled team lead by a shift leader. Please note This is a shift-based role operating 12/7 shift pattern.Bring energy, knowledge, innovation to carry out the following Perform all core production activities in DP Formulation facility.   Manufacturing processes include and Buffer, Stabilizer and Final Drug Product Formulations. Preparation of equipment for use in the Formulation and manufacturing process.    Support the development, commissioning & qualification of a new vaccines manufacturing equipment.Assist in maintaining a safety orientated Culture, cGMP compliant work environment. Responsible for completion of manufacturing tasks according to SOPs and batch records (paper and electronic).  Perform initial troubleshooting of issues identified during routine operations.  Assist with the investigation of manufacturing deviations through Quality Systems, engaging with all relevant personnel and functions as appropriate.  Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions  Seek opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S).  Where necessary assist in any in Facility and Equipment start up and Validation activities.   Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.  Provide manufacturing status update during shift handovers.  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.  Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.  What Skills You Will NeedIn order to excel in this role, you will more than likely haveCertificate, Diploma, Degree, Trade qualification or equivalent demonstrated experience of 12 months or more experience in a regulated environment, GMP environment.Experience in biopharmaceutical industry and understanding of MES operating systems.Experience with recording information in real time using electronic or manual systems.   inability to execute 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 SkillsAccountability, Accountability, Analytical Problem Solving, Batch Production, Biological Manufacturing, Biopharmaceutical Industry, Biopharmaceuticals, Cleanroom Gowning, Computer Literacy, Driving Continuous Improvement, Equipment Installations, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Laboratory Processes, Machinery Operation, Manufacturing Quality Control, Manufacturing Support, Mechanical Equipment Maintenance, Operations Management, Packaging Operations, Pharmaceutical Manufacturing, Pharmaceutical Microbiology, Process Manufacturing, Production Scheduling {+ 5 more}Preferred SkillsCurrent Employees apply HERECurrent Contingent Workers apply HERESearch 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 RegularRelocation VISA Sponsorship Travel RequirementsFlexible Work Arrangements Not ApplicableShift Valid Driving License Hazardous Material(s) Job Posting End Date 11/7/2025A 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. Requisition ID R370480