Especialista de Validação Sênior (Fixed Term: 12 Months)

Especialista de Validação Sênior (Fixed Term: 12 Months)

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

LIDER VALID SIST

Lieu :

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Lieu de travail :

Hybride

Ce que tu vas faire

The Validation Specialist 3 is responsible for providing a high degree of scientific expertise in Technical Operations for the delivery of manufacturing, packaging and cleaning validation projects for a broad range of OTC products. In addition, this professional is responsible for monitoring manufacturing, packaging and cleaning processes, and to ensure continued maintenance of the validated state. Primary activities require possessing a solid understanding of principals of validation within manufacturing.

This individual collaborates cross-functionally with Operations, Quality Assurance, Research & Development and other functions to provide subject matter expertise and technical leadership in design, development and implementation of validation requirements.

This position may require development and execution of communication plans and training programs related to manufacturing, packaging and cleaning validation principles.

Key Responsibilities

• Provide subject matter expertise and technical advice in design, development and implementation of manufacturing, packaging and cleaning validation activities in support of internal and external plants.
• Apply scientific principles to resolve validation challenges while being able to articulate technical subject matter in clear, concise terms to management, stakeholders and cross-functional teams.
• Develop, plan, implement and/or coordinate major project activities with significant business impacts in consultation with other SMES´s, site and platform leadership or department management
• Review technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
• Represent validation function in project teams and collaborate closely with Supply Chain, R&D, Quality, Regulatory and other stakeholders to ensure seamless transitions through new product development and life cycle management initiatives
• Plan, promote and organize required training activities related to different validation areas.
• Follow up on key performance metrics to ensure validation activity efficiency through process improvements and utilization of resources.
• Identify and stay up to date with emerging industry guidance for validation requirements. Investigates and communicates validation innovation and trends to improve the Supply Chain.
• Provide direction and mentorship to lower-level professionals within the organization, promoting adherence to all company guidelines related to health, safety and environmental practices.

What we are looking for

Required Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering or correlated areas is required 
• Experience with manufacturing, packaging and/or cleaning GMP validation.
• Experience with the Pharmaceutical industry is preferred. Experience in a highly regulated environment is required.
• Experience in technical writing, cGMP´s, ANVISA / COFEPRIS / FDA / ICH regulations
• Knowledge of regulatory requirements in Brazil (it is a plus previous experience with ICH, FDA, etc.)
• Knowledge in statistics (DOE, process capability, control charts, etc)
• At least intermediate English for reading and written communication;
• Demonstrated leadership skills to align multi-functional team members on delivering project deliverables
• Ability to manage complexity and to work collaboratively with critical stakeholders in local and regional levels.

Desired Qualifications

• Working experience in pharmaceutical manufacturing processes development is preferred
• Desired to be a critical thinker with problem solving skills
• Intermediate Spanish will be considered a differential
• Good communication, organizational, interpersonal and influencing skills.

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