Especialista de Validação Sênior (Fixed Term: 12 Months)

Especialista de Validação Sênior (Fixed Term: 12 Months)

O que fazemos

At Kenvue, percebemos o extraordinário poder do cuidado diário. Construída com base em mais de um século de herança e enraizada na ciência, somos a casa de marcas icônicas - incluindo NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® que você já conhece e ama. A ciência é a nossa paixão; O cuidado é o nosso talento.

Quem somos

Nossa equipe global é de ~ 22.000 pessoas brilhantes com uma cultura no local de trabalho onde cada voz é importante e cada contribuição é apreciada. Somos apaixonados por insights, inovação e comprometidos em entregar os melhores produtos aos nossos clientes. Com experiência e empatia, ser um Kenvuer significa ter o poder de impactar milhões de pessoas todos os dias. Colocamos as pessoas em primeiro lugar, nos importamos ferozmente, ganhamos confiança com a ciência e resolvemos com coragem - e temos oportunidades brilhantes esperando por você! Junte-se a nós para moldar nosso futuro - e o seu. Para obter mais informações, clique em aqui.

Role reporta para:

LIDER VALID SIST

Localização:

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

Local de trabalho:

Híbrido

O que você fará

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.

Se você for um indivíduo com deficiência, consulte nossa página Página de assistência a deficientes para obter informações sobre como solicitar uma acomodação.