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MSAT Senior Engineer (Validation)
Location:
Cork, Co. Cork
Description:
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior MSAT Engineer to join our MSAT Validation team. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. About the role The MSAT Engineer will be responsible for the following. Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP). Primary activities are in the Cleaning Validation area. Planning, documenting and performing cleaning validation studies. Leading and/or providing technical guidance for process improvement projects and investigations. Secondary activities include, but are not limited to, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Thermal Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations). Responsibilities & the impact YOU will have: * Conduct MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements. * Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval. * Review and approve documents prepared by other MSAT colleagues. * Field execution of MSAT protocols. * Liaise with Manufacturing to provide support where required with routine operations / project-based work. * Compile relevant information from contractors, suppliers, and other departments to develop technical reports. * Representing the JSI MSAT site team on platform technical teams. * Initiate and implement change control activities in accordance with site procedures. * Track and resolve exceptions/events/deviations during MSAT activities. * Prioritize MSAT activities in line with Manufacturing / the particular project schedule. * Co-ordinate MSAT activities with contractors and vendors as required. * Attend identified training, required to fulfill the role of a MSAT Engineer. * Participate in multi-functional teams (project, investigations) as required. Requirements for the role Required: * A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required. * At least 3 yrs experience in the Large Molecule manufacturing industry or equivalent. * Focus on patients and customers at all times. Desirable: * Experience in biological Cleaning Validation (Minimum 2 years). * Also, beneficial would be experience in Projects, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Thermal Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation. * Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests. * Ability to work independently under general direction, having a good sense of prioritization of goals and good time management. * Ability to lead multi-functional team and to manage complexity and change. * Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. This is what awaits YOU at J&J: We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you're one of the 1000 people who work here, or you're considering joining the team, we offer: * An opportunity to be part of a global market leader. * A dynamic and inspiring working environment. * Opportunities to work on ambitious projects and assignments. * Possibilities for further personal and professional development/education * Excellent Benefits
Company:
Johnson And Johnson
Posted:
June 28 on Equest
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More About this Listing: MSAT Senior Engineer (Validation)
MSAT Senior Engineer (Validation) is a Engineering Engineer Job at Johnson and Johnson located in Cork C. Find other listings like MSAT Senior Engineer (Validation) by searching Oodle for Engineering Engineer Jobs.
MSAT Senior Engineer (Validation) is a Engineering Engineer Job at Johnson and Johnson located in Cork C. Find other listings like MSAT Senior Engineer (Validation) by searching Oodle for Engineering Engineer Jobs.