Job DescriptionAssoc. Spclst, Operations - Aseptic ExcellenceA fantastic opportunity has arisen for a Assoc Specialist, Operations (Aseptic Excellence Training Team)The Aseptic Excellence Operations Specialist should have cleanroom and manufacturing shop floor experience, strong technical writing skills, and knowledge of risk assessment and Good Documentation Practices (GDP). Project experience is a plus. Responsibilities include generating and reviewing GMP documentation, conducting process investigations, completing quality notifications, delivering aseptic training, maintaining process documentation systems, and supporting batch release while ensuring compliance with cGMP standards and global regulations. The specialist will also promote a safe and compliant culture and may assist with IPT training management.What you will do:Bring energy, knowledge, innovation, and leadership to carry out the following:Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.Be a document system expert; this will include document review, approval, and document system workflow expedition.Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.Required to deliver aseptic training to new starts as well as refresher training.Support operation activities through documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases including the maintenance, auditing, and archiving of the process documentation system.Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.Work collaboratively to drive a safe and compliant culture in Carlow.May be required to perform other duties as assigned.Assist in the management and/or assignment of IPT training if required.What skills you will need:In order to excel in this role, you will more than likely have:Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other technical disciplineRelevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.Excellent communication, presentation, and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports. Strong team skills, including ability to coach/develop work teams.Excellent training, facilitation, and assessment skillsRisk management skills. Strategy planning and development Demonstrable analytical and systematic problem-solving skills o Strong influencing skills o Flexible approach Effective time management and multi-tasking skills o Proven organizational skills o Excellent attention to detail.Trouble shooting skills.Goal/results orientated.At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.Our Commitment to Ireland:Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.As a company, we are committed to ‘Inventing for Life’ in all that we do. 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.Current 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 Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:03/10/2025*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.