Senior Engineer MSAT Materials

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Johnson & Johnson is hiring for a Senior Engineer - MSAT Material Sciences! This position is located in Leiden, Netherlands.

Are you interested in joining a team that is positively impacting patients' lives by ensuring efficient and effective manufacturing of our biopharmaceutical products? Apply now for this exciting chance to build and lead our MSAT Materials team!

Within the J&J Innovative Medicine Manufacturing Sciences and Technology (MSAT) Biotherapeutics Drug Substance team, you will be responsible for the lifecycle management and scientific understanding of raw materials used in the manufacturing of biotherapeutic drug substances and drug products. Activities include risk assessments of raw materials, technology transfer support and inputs into regulatory filing and inspection support. Raw materials include cell culture media, chemical, resins, excipients and polymeric/single use systems.

You will work in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.

Key Responsibilities:

• Lifecycle Management (LCM) raw material control strategies including supplier/material reliability, specification management, and critical material attribute monitoring
• Lead and direct technical support to MSAT, operations and QC, including assisting in investigations
• Interpret and implement industry and regulatory guidance for raw materials, ensuring compliance with GMP, quality, and scientific principles
• Author, review, and approve documents for global filing updates of J&J biotherapeutics drugs
• Lead continuous improvements supporting quality and business goals

Qualifications:

Education:

• Minimum of a Bachelor's or equivalent University degree required; Master's or focused degree preferred in Chemistry, Biology, Materials Science, Engineering, Pharmacy/Pharmaceutics, or related field

Experience and Skills:

Required:

• Biopharmaceutical manufacturing processes and understanding of raw material structure and function
• Quality investigations and deviations, material change risk assessments, regulatory questions and submissions
• Written and oral communication skills and ability to influence peers, superiors, and partners, while collaborating within a cross-functional team
• Motivated, self-starter able to work independently with demonstrated problem solving skills

Preferred:

• Experience in change management and document management systems
• Experience in a production planning and/or quality role
• Demonstrated proficiency leading and participating in complex technical project in matrix environment