Senior MSAT Engineer
Role: MSAT Senior Engineer (Life Cycle Management)
Department: Manufacturing Science and Technology (MSAT)
Reports to: MSAT Manager
Location: Ringaskiddy, Cork, Ireland
Travel: 5-10% (potential)
Global Compensation Framework Band Number: 25
Company Summary:
Janssen Sciences Ireland UC is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. In 2017, we invested a further €300 million in the expansion of our manufacturing plant and created 200 additional jobs. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.
Position Summary:
We are currently seeking a MSAT Senior Engineer to join our Life Cycle Management (LCM) Team at our facility in Ringaskiddy, Cork, Ireland. As a leading manufacturer of healthcare products, Johnson & Johnson is committed to enhancing patient well-being worldwide. In this position, your contributions will be integral to maintaining the efficiency of our manufacturing processes and the continued success of our products.
Main duties and responsibilities:
- Apply your outstanding technical expertise to offer second-line support to our Manufacturing Operations team, with a specific focus on our commercial products.
- Take ownership of the technical aspects of our commercial products, leading and coordinating any necessary changes and providing support for manufacturing-related discussions.
- Lead and contribute to process improvement projects, commercial product scale-up initiatives, and new product introductions, ensuring the successful implementation of these endeavours.
- Drive the adoption of new technologies that enhance our manufacturing processes, constantly striving for excellence and innovation.
- Coordinate and oversee life cycle management activities, including Process Qualification and Continued Process Verification, to ensure our products meet the highest quality standards.
- Serve as a representative of our Cork MSAT site team on Platform technical teams dedicated to life cycle management.
- Prepare, review, and approve technical documents, CAPAs, change control requests, investigations, protocols, reports, and SOPs, while ensuring compliance with regulatory requirements.
- Provide technical support and expertise during complex multi-functional investigations, collaborating with Quality and Operations teams.
- Support and actively participate in regulatory audits and inspections, working closely with Quality and Operations to ensure compliance.
- Collaborate effectively with teams from various departments to drive successful project outcomes.
- Perform all tasks according to US and EU regulations, Johnson & Johnson protocols, and guidelines for environmental health, safety, and sustainability.