This is what awaits YOU at J&J: • An opportunity to be part of a global company • A dynamic, inclusive and inspiring working environment • Many opportunities to work on challenging projects and assignments Qualification Engineer - MAM (TD) 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/ .
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
For the Italian production plant of Janssen (Borgo San Michele-Latina) we are looking for an Qualification Engineer to be hired with a TEMPORARY CONTRACT in the Make Asset Management Department and will report to the C&Q/CSV Manager.
The Qualification Engineer will be part of a team that is involved in all Projects of the Site having the responsibility to ensure the GMP/EHS compliance qualifying standard and innovative Technology.
Main responsibility As first assignment the Qualification Engineer will be crucial in managing qualification activities and processes in the packaging area, with the following main responsibilities: • Support in the introduction of new technologies and NPI, in line with the project portfolio • Definition and oversight of the testing strategy • Management and review of project documentation, ensuring compliance with Johnson & Johnson's GMP/EHS standards • Active collaboration with all business functions and plant areas The Qualification Engineer oversees: • Planning and coordination of the activities in collaboration with the various departments involved in the implementation of the projects.
• Proactively identifying risks to define mitigation strategies.
• Assess the business impact, quality, compliance and safety involving stakeholders from other departments.
• Ensure compliance with the time of introduction, balancing the base business production needs.
• Ensure timely communication to C&Q/CSV Manager and Projects Managers to align with the production plans themselves.
• Ensure the timely availability of quality documentation for the project execution.
• Performs and/or support investigations for non-conformances in case of occurrence during project activities.
* Italian speaker.
Fluent in English (B2 level and above) is required.
* Master's degree in engineering (preferred), Farmacy, CTF or Chemistry * At least 12 months experience in the pharmaceutical industry (Oral Solid production is preferred) * Academic knowledge of lines, processes, materials and equipment for pharmaceutical process (oral solid pharma production competence is preferred).
* Good knowledge of quality, compliance and GMP/EHS related to manufacturing and packaging of pharmaceutical products.
* Basic experience in Project Management.
* Able to work in a multidepartment and dynamic environment and to deal urgencies on the shop floor.
* Ability to coordinate a cross functional team to ensure the correct execution of the project activities according to the agreed timing.
* Skills of ownership and accountability.
* Skilled in problem-solving and decision making.
* Capacity to lead calls with third parties.
* Capability to easily connect with people and prepare smart proposals for project approaches.
* Excellent oral and written communication skills.
* Ability to present scientific data and concepts effectively to international standards.
It is essential for the candidate to demonstrate autonomy, initiative, and strong skills in connecting and mediating between cross-functional teams.