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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is hiring for a Senior Engineer - MSAT Materials. This position is located in Cork, Ireland.

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 Supply Chain, Manufacturing Sciences and Technology (MSAT) Biotherapeutics has formed a new MSAT Material Sciences team. The Senior Engineer MSAT Materials will be part of the growing team that is responsible for lifecycle management of raw material, excipients and consumables technical, quality and business requirements to optimize product quality, value and ensure regulatory compliance of commercial portfolio.

Key Responsibilities:

• Lifecycle management of material technical qualification and specifications in close collaboration with partners in procurement, quality, MSAT, R& D and suppliers
• Develop scientific based rationale to advise single-use-systems controls at supplier, site and process level
• Identify and implement mechanism to continuously monitor single-use-systems variability and impact to process
• Complete Extractables & Leachables assessments in support of drug substance and drug product technology transfers and lifecycle management
• Interpret and implement industry and regulatory guidance for materials, ensuring compliance with GMP, quality, and scientific principles
• Author, review, and approve raw material sections of regulatory documents for global filing updates of JnJ biopharmaceuticals
  

Qualifications:

Experience and Skills:

Required:

• Demonstrated competency and experience in biopharmaceutical manufacturing processes and technology transfers
• Demonstrated proficiency in qualification and assessment of single use systems
• Good knowledge of GMP and applicable pharma regulations
• Demonstrated experience working effectively in matrix team.

Preferred:

• Experience in change management and document management systems
• Experience in design of experiments and coordination with internal and external lab personnel
• Demonstrated proficiency leading complex technical project in matrix environment
• Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies

Other:

• May require up to 10% domestic and international travel, depending on business needs and work location