Experienced Sterilization Validation Engineer MSAT

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:
Beerse, Antwerp, Belgium

Job Description:

Johnson & Johnson is looking for a Sterilization Validation Engineer MSAT to join the MSAT (Manufacturing Science and Technology) team located in Beerse, Belgium.

The Manufacturing Science And Technology (MSAT) Engineer is a member of the MSAT Sterilization Validation Team with the dedicated focus on:

              


* New Product Introduction (NPI) / Life Cycle Management (LCM)


* Validation Master Plan execution


* Process improvements


* Standards and new technology deployment

The MSAT Engineer is expected to continuously focus on safety, quality, GMP and operational discipline.

He is responsible for the management and/or execution of the Validation Master Plan(s), including but not limited to sterilization validation, optical inspection and aseptic process simulations (Media fill and Process Simulation Testing).

The MSAT Engineer is a key contributor to NPI / LCM and process improvement initiatives on the site.

KEY RESPONSIBILITIES:


* Responsible to maintain the validation status of systems and processes in commercial manufacturing related to existing products, product transfers, changes and new product introductions.


* Responsible as SME for sterilization cycle development, sterilization validation, optical inspection and aseptic process simulations (Media fill and Process Simulation Testing).


* Responsible for maintenance of master recipes (parameters) of sterilization systems (autoclaves, SIP, isolators, …). 


* If needed, support of activities across the three functional areas within MSAT (process, cleaning and sterilization validation).


* Maintain a current knowledge of international regulations, guidelines and industry practices related to sterilization validation, optical inspection and aseptic process simulations (Media fill and Process Simulation Testing).


* Ensure contemporary validation standards are followed.


* Participate in system and process improvement / optimization projects.


* Participate in product transfer, new product introduction and system introduction teams, as FPX core team member (if needed).


* Assure revalidation of sterilization processes, optical inspection or APS for existing equipment triggered by changes to the m...