About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Want to make a global impact? We offer that. Want to be part of a Great Place to Work in Ireland? We offer that too. Welcome to AbbVie! We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work. We are now recruiting a QA Validation Specialist Engineer to join our diverse Quality Assurance Validation Team in Clonshaugh, Dublin. Their primary focus will be to enhance and maintain the quality oversight and compliance systems of validation activities on the Clonshaugh site. This position will primarily be involved in supporting and coordinating day to day activities in the areas of cleaning, facilities and equipment validation and will participates in knowledge transfer activities to become a QA Subject Matter Expert on new and developing processes. Are you intrigued? Do you want to learn more? A snapshot of your key responsibilities as QA Validation Specialist Engineer would be: Author, review, issue IQ/OQ/PQ protocols for equipment and facilities and report on executed proto-cols, as required. Develop cleaning validation protocols and reports to ensure compliance to regulatory requirements post cleaning activities Assist in the management of the site Validation Master Plan and its timely execution. Participate as a SME providing quality oversight and regulatory advice for projects with other depart-ments such as Engineering, Pharm. Tech, Equipment Maintenance, Manufacturing, Facilities and QA Process Support. Act as a site contact for vendors where required, including off-site meetings where applicable (e.g. F.A.T) Provide QA support for Laboratory equipment qualification. Review and approve protocols and re-ports. Maintain the site equipment calibration programme and ensure equipment performance is continually demonstrated. Track and report performance of on-site calibration program. Contribute to the execution of feasibility studies. Review and contribute to the development of User Requirement Specifications. Provide a review and approval of all vendor supplied documentation. Generate / contribute to risk assessments as required. Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investiga-tions, CAPAs, reports and forms. Qualifications So, what do you need to do this role? Education & Experience Bachelor’s Degree required in a scientific or engineering discipline. Engineering degree preferred. Minimum of 5+ years’ experience in the pharmaceutical industry with excellent working knowledge of cGMP and Solid Oral Dosage is required. Strong analytical skills combined with the ability to trouble shoot and knowledge of FDA/EMA regula-tory requirements essential. Equipment, Facilities, Utilities and Process, Cleaning, Validation knowledge and / or experience is pref-erable Experience with TrackWise, eDocs, and SAP are preferable Excellent Protocol / Report writing skills are required. So, are you ready to join our team? It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.