Qualification Engineer

2 settimane fa

Lazio, Italia Buscojobs A tempo pieno

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 At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, 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.

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.

For the Italian production plant of Janssen (Borgo San Michele-Latina), we are looking for a Qualification Engineer to be hired with a TEMPORARY CONTRACT in the Make Asset Management Department, reporting to the C&Q / CSV Manager.

The Qualification Engineer will be part of a team involved in all Projects of the Site, with the responsibility to ensure GMP / EHS compliance qualifying standards and innovative Technology.

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.

Planning and coordination of activities in collaboration with various departments involved in project implementation.

Proactively identifying risks to define mitigation strategies.

Assess 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 production plans.

Ensure timely availability of quality documentation for project execution.

Perform and/or support investigations for non-conformances during project activities.

Qualifications: Italian speaker.

Fluent in English (B2 level and above) is required.

Master's degree in engineering (preferred), Pharmacy, CTF, or Chemistry.

At least 12 months experience in the pharmaceutical industry (Oral Solid production preferred).

Academic knowledge of lines, processes, materials, and equipment for pharmaceutical processes (oral solid pharma production competence 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 multi-department and dynamic environment and manage urgencies on the shop floor.

Ability to coordinate a cross-functional team to ensure correct execution of project activities according to agreed timing.

Skills of ownership and accountability.

Skilled in problem-solving and decision making.

Capacity to lead calls with third parties.

Capability to 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.

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