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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

IE004 Barnahely, Leiden, Netherlands

Job Description:

Johnson & Johnson is hiring for a Senior Engineer - MSAT Materials. This position is located in Leiden, Netherlands or 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

About Institution of Chemical Engineers (IChemE)

Founded in 1922, the Institution of Chemical Engineers (IChemE) is the UK based and internationally recognised qualifying body and learned society for chemical, biochemical and process engineers. We exist to advance chemical engineering’s contribution for the benefit of society.

IChemE members can be found in a wide range of industry sectors, and at different stages of their careers. They play a key role in our governance and day-to-day operations. IChemE is led by members, supports members and serves society.

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