Manufacturing Specialist – Dublin Respiratory
Viatris
- Baldoyle, Co Dublin
- Permanent
- Full-time
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.The Role & What You Will Be DoingInclude introductory paragraph here if availableEvery day, we rise to the challenge to make a difference and here’s how the Manufacturing Specialist – Dublin Respiratory role will make an impact:Support MES, Manufacturing, Validation, Automation, Quality, Process Systems and Projects.Work flexibly across the areas mentioned above taking account of their experience and training.By specifying, designing, and implementing MES Systems projects including a structured handover and post implementation support until Business Benefits realisation.Measure, analyse and improve Manufacturing process outputs.Prepare product and process reports by collecting, analysing, and summarizing information and trends, including Quality Deviations caused by both equipment or personnel.Deliver improvement initiatives across both Products and Processes.Assures product and process quality by testing product and process capabilities; establishing standards; confirming manufacturing processes optimization.Specify, Design, and implement Automation Systems.Provide Qualification and Validation support.Promote and implement Safe Working in all work areas and projects.Assist in the development, implementation, and facilitation of technical/non-technical training programs and coursework designed to ensure that relevant personnel are trained and qualified to perform their assigned duties in a compliant, effective, and efficient manner, covering all Manufacturing Operations (equipment and processes).Provide guidance and apply expertise to the functional groups in the assessment of training needs and the development of effectiveness metrics.Assist and support colleagues, supervisors and management in the development and implementation of technical and non-technical courseware to support functional operating groups.Perform duties in compliance with all applicable regulatory agencies, Standard Operating Procedures (SOPs), and Company policies.Ability to progress Human error related QI/QIRs through the TrackWise system, proposing and implementing effective CAPAs which result in a reduction in the assigned Human error type per relevant Work Centre grouping.Support the QMS Teams and remediation team periodically with investigations and closure of QI’s and CAPA’s.Support Change control proposals and assist with CMS Task closures.Support improvements in manufacturing RFT performance and facilitate training and reduction of EBR errors. Facilitate the analyses of data generated and RFT reporting.About Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Five years + relevant experience within the Pharma/Medical Device or related industries, with ability to train other people.Ideally, the candidate will have a third level qualification in a relevant discipline. In that regard, a Mechanical/Mechatronic/ Engineering graduate would be at a distinct advantage.If the candidate does not have a relevant third level qualification, then they should be on the path to achieving that qualification or have sufficient manufacturing and systems experience to meet the requirements of the role.Experience of Dry Powder Inhalers, powder handling, component moulding and assembly would be advantageous.A working understanding of appropriate regulatory requirements, including 21 CFR Parts 210/211, ISPE/ICH Guidelines (including ObD enhanced approach) and EudraLex would be an advantage.Lean/Six sigma certification would also be advantageous.Provide shift support across single, 2, 3 or 4 shifts to meet business needs as required.Must possess knowledge of pharmaceutical manufacturing, packaging, and testing processes; knowledge of Mylan policies and procedures; knowledge of domestic and international good manufacturing practice (GMP) regulations.Must possess computer skills including high proficiency in the use of Microsoft Office, with the ability to learn new software applications used for tracking or delivering training and projects.Must have the ability to read and interpret complex business and/or technical documents; to write comprehensive reports and detailed business correspondence.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.Benefits at ViatrisAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:Excellent career progression opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & Inclusion at ViatrisAt Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visitSustainability at ViatrisCorporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer.