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Johnson and Johnson is recruiting for a Senior Material Excellence Engineer LCM to be preferably located in Belgium Europe. The Senior Material Excellence Engineer LCM is part of the Life Cycle Management (LCM) team withing Advanced Therapies MSAT (Manufacturing Science and Technology).

The team

Excelling in science and technology, the Life Cycle Management Team within MSAT Advanced Therapies works passionately on bringing technological innovations to our patients. We are a fast-developing group and forward-looking, working on improving technical processes, being customer-focused and support the need for speed. This team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

The role

This role will lead global implementation of critical material projects that will drive reliability, innovation and sustainability in our processes and plants across the globe, both internally and externally. The successful candidate is therefore able to appropriately balance the requirements at all manufacturing sites as it relates to multiple in-flight programs/indications: early development, clinical trials, and commercial activities. The capability to effectively facilitate change activities including the ability to navigate within a global network and collaborate effectively with internal and external partners will be key to drive critical programs to successful completion. This role will work in a cross functional setting and must have strong communication skills to foster collaboration and drive success across the organization. Up-to-date knowledge of industry standards, regulatory requirements and pharmaceutical manufacturing processes related to cellular therapies are highly desirable as well as expertise in CCI (Container Closure Integrity) techniques and regulatory requirements and guidelines with a proven ability to streamline approaches, guide strategies and align processes across multiple manufacturing sites.

Key Responsibilities:

• Collaborate with cross-functional teams to optimize network performance, quality, and compliance, while implementing standard processes in supply chain, logistics, and distribution to boost operational efficiency.

• Lead process improvement initiatives, introducing new materials or technologies to enhance reliability and drive innovation across processes and plants.

• Drive the CCI strategy for advanced therapies products, ensuring robust and aligned controls are in place, and developing new strategies when needed in alignment with regulatory requirements and guidelines.

• Develop and monitor KPIs to track performance, identify improvement areas, and support resource optimization to reduce costs.

• Drive organizational change through effective change management and communication strategies.

• Identify potential risks, develop mitigation plans, and ensure smooth operations, including local adaptations aligned with global strategies.

• Assess operational differences within the network to enable efficiencies and support the creation of business cases for improvement projects, considering risk, financial, and regulatory factors.

Qualifications

Education:

• 7+ years of relevant experience and BS degree OR 4+ years with advanced degree MS/MBA/Ph.D.

Experience and Skills:

Required:

• Experience working in a pharmaceutical environment

• In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA, FDA, etc.)

• Project Management skills and the ability to interface cross-functionally with other areas of expertise

• Understanding of drug development, manufacturing processes and submission requirements

• Knowledge and experience with CCIT techniques, regulatory and guidelines requirements

• Ability to work independently and in a matrixed team environment

• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution

Preferred:

• Competency and experience with introduction of biological products to manufacturing sites

• Cell/ gene therapy or material experience

Other:

• 10% travel may be required, depending on project needs