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Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Latina, Italy

Job Description:

MSAT Scientist – Cleaning Validation

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

 

Purpose:

We are seeking a MSAT Scientist to join the cleaning validation team  supporting and driving the implementation of cleaning projects across new product introductions, lifecycle management, and new technologies, ensuring the highest standards of quality, compliance, and safety.

The person will report to the MSAT Cleaning Sr Manager.

The MSAT Scientist is in charge to:

• Coordinate and perform the validation activities of cleaning through issuing of relevant documentations according to global and local procedures.
• Coordinate and perform revalidation of cleaning processes in accordance to the related master plans. Assess the validation impact upon requests for change.
• Manage change of control of cleaning projects and cleaning validation impact assessment
• Provides input to develop cleaning validation protocols, reports and other related documents.
• Performs and/or support investigations for non conformances issued during project activities.
• Coordinate activities with the manufacturing personnel, laboratories and other groups to perform cleaning validation runs and tests.
• Supports specific NPI and/or technical transfer projects for existing products by executing characterization, registration, and validation phases, ensuring alignment with internal and external stakeholders and maintaining the highest standards of quality & compliance  and safety
• Support analysis of the new potential CIP/improvement projects for Technical Operations projects and elaborate implementation plan
• Support Data Integrity program in the cleaning area and lead specific initiatives
• Manage communication with the main supplier and stakeholder
• Coordinate the internal activities for the launch of products on different markets respecting the timelines agreed with the external organizations.
•  Assess the impact upon requests for changes.

Requirements/Skills and Qualifications:

• University Degree in scientific/ technical field or an equivalent combination of education and experience in pharmaceutical context.
• At least 7 years of professional experience
• Strong skills of leadership, ownership and accountability
• Experience in Quality and Compliance inspections
• A strong background in Quality and a cross-functional experience (Quality, Quality Control or Operations) is considered a plus
• Skilled in problem-solving, decision making and project management
• Ability to work in a multidepartment and dynamic environment and to deal with urgencies on the shop floor
• Capability to easily connect with people
• Fluent in English and Italian (B2 level and above)
• Results driven mindset

 

 

Required Skills:

 

 

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

  

 

The anticipated base pay range for this position is:

€48 600,00 - €77 395,00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.