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Learn more at Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Chemical Research Job Category: Scientific/Technology All Job Posting Locations: Ringaskiddy, Cork, Ireland Job Description: 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.
Key Skills and Proficiencies required: To excel in this role, you will need to possess the following skills and proficiencies: * Excellent interpersonal skills, allowing you to effectively collaborate and communicate with colleagues at all levels.
* Strong critical thinking ability, enabling you to analyse complex problems and develop innovative solutions.
* Exceptional written and verbal communication skills, ensuring clear and concise communication of technical information.
* Meticulous attention to detail to ensure accuracy and quality in all tasks.
* Demonstrated capacity to think innovatively and effectively apply problem-solving skills to overcome obstacles.
* Actively focuses on achieving goals and consistently delivers exceptional outcomes through your work behaviours.
* Adaptability and flexibility to successfully navigate a dynamic and fast-paced work environment.
* Demonstrated integrity, trustworthiness, and objectivity in all professional interactions.
* In-depth knowledge of FDA/EMEA regulatory requirements, ensuring compliance throughout all activities.
Education and Experience: Required: * A minimum of a Degree in Science or Engineering.
* At least 2 yrs experience in GMP * A genuine focus on patients and customers always, keeping their needs at the forefront of your work.
Desirable: * Experience in Bio-pharmaceutical manufacturing (Large Molecule API) processes and equipment.
* Proficiency in process excellence methodologies such as 6sigma, lean concepts, and statistical skills.
* Proven ability to lead multi-functional teams and effectively manage complexity and change.
* Excellent communication skills to effectively engage with individuals from different teams within the organization and handle diverse perspectives.
* Ability to work independently under general direction, demonstrating excellent goal prioritization and time management skills.
* Demonstrated knowledge and application of industry regulations, including FDA, HPRA, EMEA, and other relevant authorities.
At Johnson & Johnson, we believe that a diverse and inclusive workforce drives innovation and success.We welcome applicants from all backgrounds and are committed to providing equal employment opportunities to all individuals.Join our ambitious team today and contribute to our mission of improving lives through groundbreaking healthcare solutions.
Apply Now: To apply for this position, please submit your resume and cover letter via our online application portal.