C&Q/CSV Manager

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 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

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
People Leader

All Job Posting Locations:
Latina, Italy

Job Description:

Johnson & Johnson Latina site is a leading company in pharmaceutical sector dedicated to delivering high-quality solutions and services that meet the needs of our clients.

We pride ourselves on our innovation and commitment to excellence.

Job Summary:

We are seeking a highly motivated and experienced Commissioning & Qualification /C&Q) / Computer System Validation (CSV) Manager to oversee and manage the commissioning and qualification processes for our projects.

The ideal candidate will have a strong background in oral solid pharmaceuticals, be detail-oriented, and possess strong leadership skills.

Key Responsibilities:


* Lead and manage all C&Q / CSV activities for projects, ensuring compliance with regulatory standards and industry best practices.


* Develop and execute commissioning and qualification plans, protocols, and reports.


* Coordinate with cross-functional teams including engineering, operations, quality assurance, process validation and project management to ensure alignment on commissioning and qualification deliverables.


* Conduct risk assessments and develop mitigation strategies related to commissioning and qualification activities.


* Contributes to the annual definition of the CAPEX and OPEX budget necessary for the execution of the projects.


* collaborates with the corporate team in defining and maintaining the methodology


* Supervise, train, and mentor junior C&Q team members, fostering a collaborative and high-performance culture.


* Maintain up-to-date knowledge of industry regulations, trends, and best practices in commissioning and qualification.


* Communicate effectively with stakeholders, providing regular updates on project status, risks, and issues related to C&Q activities.


* Participate (key spoken person) in audits and inspections related to commissioning and qualification processes.
 

Qualifications:


* Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.


* A minimum of 10 years of experience in commissioning and qualification / quality assurance within pharmaceutical sector.

Experience in oral solid production process (including continuous manufacturing), automation projects preferred


* Strong unde...