Senior BioProcess Associate - Fill Finish

Job description

Job Description We are looking for a Senior BioProcess Associate to join our Drug Product team at our state-of-the-art, fully integrated vaccine facility in Dundalk, Ireland. This is an exciting opportunity to be part of a fast-growing, dynamic team working with cutting-edge technology at the forefront of vaccine manufacturing. Bring energy, knowledge, and innovation to carry out the following: Perform core production activities in the Drug Product facility, with a high level of autonomy and accountability. Operate equipment for formulation, filling, lyophilization, capping, and inspection. Serve as a subject matter expert (SME) in Drug Product for the team, providing guidance, technical support, and best-practice leadership. Support commissioning, qualification, validation, and start-up activities for new equipment and processes. Complete manufacturing tasks in line with SOPs and batch records, both paper and electronic. Maintain a safe and cGMP-compliant work environment. Troubleshoot routine issues and support deviation investigations through the Quality System. Write, review, and revise SOPs, batch records, logbooks, training competencies, work instructions, and job aids. Support Continuous Improvement initiatives using Lean/Six Sigma tools and Standard Work principles. Provide updates during shift handovers and contribute to team KPI delivery, including Safety, Quality, Schedule Adherence, OEE, and training. Mentor, train, and support the development of other team members in Drug Product operations, helping to build capability and consistency across the team. Support Maintenance, Engineering, Quality, and other functions as needed. What skills you will need: In order to excel in this role, you will more than likely have: Certificate, Diploma, Degree, Trade qualification in Science, Engineering, or equivalent. 5 years’ experience in a regulated environment, ideally within biopharmaceutical or Drug Product operations. Demonstrated experience working as part of a team and recording information in real time using electronic or manual systems. Experience following SOPs, batch records, and manufacturing control systems. Strong communication, attention to detail, documentation, and problem-solving skills. Ability to work independently and as part of a self-managed shift team in a fast-paced environment. Proven experience mentoring, coaching, and training others, with the ability to share knowledge effectively and support team development. Strong technical understanding of Drug Product operations and the ability to act as a go-to resource for the team. Preferred: Experience in the biopharmaceutical industry. Experience working in Grade B, C, D, and CNC environments. Experience in Drug Product operations. Experience in start-up operations. Experience in a fast-paced environment. 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. Our Companies in Ireland is one of the country’s leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. Required Skills: Aseptic Operations, Bioprocessing, Cleanroom Gowning, Drug Product Manufacturing, GMP Documentation, Good Manufacturing Practices (GMP), Master Batch Records, Pharmaceutical Manufacturing Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description: 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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. 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: 08/26/2026*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.