Global Cleaning Validation SME
Johnson & Johnson
Pomezia (Santa Palomba), IT
12 gg fa

Global ConsumerCleaning Validation Leader is responsible to set up a new approach for consumer validation and be the focal point for the execution, maintenance, and continuous improvement of the JJFCC Cosmetics Cleaning validation program, in fully integrated way with the other Process and Packaging Validation Leaders.

The Global Validation organization is improving the standard and deliver consistently the cleaning process across the different regions and aligned with the stakeholders requirements and their committed support.

Within this scope, this role will ensure global consistency of the Cosmetic Cleaning validation procedures within both the J&J Internal and Third Party Manufacturing network, and the local / site execution to identify and implement program improvements including, but not limited to, resourcing, compliance and risk management.

The Consumer Products Validation Program will include appropriate lifecycle management and periodic monitoring of commercial process performance.

The Global Cleaning Validation SME is responsible for management of the approach and strategy related to Cleaning Validation, Sanitization and product sterilization where applicable (example band aid) of JJFCC Products across the 3 regional Consumer Validation organization, to ensure compliant and efficient performance consistent with established J&J guideline and policies.

  • Support the Regional Validation Leaders in deployment of defined standards and strategies within their respective region, specifically for each technological area, he / she connects and drives the regional Validation OWNER developing, finalizing and supporting implementation, for cleaning validation strategy, design control, acceptance criteria definition, as well as standard protocols and reports.
  • He / she is the owner of Cleaning validation, sanitization and device sterilization, qualification policies, procedures, programs related to cleaning, integrated equipment and automated systems where applicable.

    Additional responsibilities include :

  • Be well-versed in the principles and approaches of process validation in the regional Consumer organization
  • Be well-versed in the principles and approaches of Equipment qualification and CSV integrated with Cleaning / sanitization systems in the regional Consumer organization
  • Ensure regional validation staff is available and adequately prepared and trained to execute validation objectives
  • Support the development and continuous optimization of JJFCC Consumer Products Validation program improving approaches to validation execution based upon risk management approach.

    Manage coordination with J&J Center for Cleaning Evaluation (CCE) to align on trends and give feedback from Consumer user needs, as well as integration with other GTO departments.

    Have a direct responsibility to deploy the globally defined Cleaning standards within the region aligning with the Global Technology leaders.

  • Serves as Subject Matter Expert and Point Of Contact (SME-POC) on the team and provide validation oversight and guidance, local oversite could be necessary.
  • Responsible for communicating and elevating critical business-related issues as well as opportunities to senior management.

  • Is the Cleaning Validation / Sanitization front end in the local Health Authorities inspection supporting the site people / organization.
  • He / she is active contributors in Plants or validation Hubs, and promotes and organizes required training activities related to different validation areas.
  • Participates in establishing key performance metrics to evaluate validation efficiency, being present in case of validation needs, J&J and health authorities inspection .

  • The Cleaning Validation SME also support Global / Regional Leader to manage all validation resources within the region.
  • This includes setting goals and objectives, performance and development planning and any other aspects related to people management responsibilities like training.

    Available and flexible to travel to meet business requirements.

  • Actively contributing to professional development of the team and achieving goals.
  • Support Global Leaders in definition of regional functional operational budget for his / her area of competence connecting with global level as well as the specific geographical area of responsibility.
  • Establishes and ensures the rigor of testing during all qualification / validation activities to be consistent with International and local applicable Authorities as well as Company requirements.
  • Perform the work in compliance with GMP and Compliance standards for activities where applicable.
  • Contributing to the company achievement and departmental objectives while respecting corporate procedures governing the employment relationship and ethical conduct principles
  • Contributing to the improvement of the quality of the work environment by promoting and encouraging actions consistent with the Corporate Credo
  • Cooperate actively with production Make departments, R&D, SMP, Engineering, GP, QA and QC planning to ensure completion of validation activities in the required mode and time.

    He / she supports investigation of validation problems and in cooperation with the Quality organization in wider investigations

    Always report to the Global Technology Leader all those situations that could endanger the health and safety of workers and / or the environment.

    Contribute to the containment of departmental costs, contributing to the improvement and optimization of business processes

    Define and implement PE projects and CIP projects

    QUALIFICATIONS

    1 Required Education / Training and / or Experience :

  • Bachelor degree in Physical Sciences, Biology, Biotechnology, Engineering, or appropriate related equivalent field
  • 5-6 years experience in related field. GMP knowledge is required. Cosmetic and OTC product knowledge is strongly preferred.
  • Equipment Qualification is preferred.

  • 2+ years experience performing process, cleaning, or other validation in a regulated environment; strong knowledge of principles in validation and current industry approaches
  • 2+ years experience managing direct reports and / or cross-functional team (R&D, SMP, Validation, Packaging Development, or Procurement).
  • 1+ yr. of Project Management experience strongly preferred
  • Experience in Health Authorities inspection management strongly preferred as well as product sterilization expertise.
  • 2 Required Skills / Abilities :

  • Experience with leadership and conflict resolution skills
  • Effective written and oral communication skills (English is a requirement)
  • Knowledge of team dynamics
  • Broad business acumen with knowledge of project related finance
  • Knowledge of planning and organization
  • Experience with new product development processes and terminology
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