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 manufacturing process.
• Responsible for execution and coordination of the Validation Master Planning.
• Communication with EWF platform lead (SPOC) related to validation projects and activities.
• Write, review and SME approval of sterilization validation related project plans, protocols and reports.
• Write and/or review of VMP’s.
• Review of Master Batch Records.
• Be involved in trouble shooting and quality investigations.
• Contribute to Standardization initiatives for MSAT.
• Act as a subject matter expert for the sterilization validation impact assessment of change controls.
• Prepare for internal and external inspections. Be spokesperson and Subject Matter Expert during inspections.
• Participate in Community of Practice (CoP) teams (global) on subjects (VHP, steam/heat, …) of sterilization validation. 

Qualificationseducation:

• Bachelor degree (BS) in a technical field: Engineering, Science, or Pharmaceutical Sciences.

Master degree in Science (MSc) is a plus.

Experience And Skills:

Required:

• Strong interest in working in a pharmaceutical environment with focus on drug product processes and materials.
• Expertise on pharmaceutical manufacturing processes & products and/or equipment & facility engineering (if applicable) especially for the involved technology platform.
• Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for the involved technology platform.
• The ability to work both independently and in a team environment. 
• A hands-on can-do mentality and the agility to work with stretched goals
• Strong interpersonal and communication skills both in spoken and written Dutch and English to be able to effectively collaborate with operators, technical & quality experts
• Strong analytical skills and the ability to work accurately
• Adhere to applicable cGxP’s and procedures

Preferred:

• At least 3 to 5 years of meaningful experience in pharmaceutical development or manufacturing
• Understanding how to perform in cross-functional project & issue management teams and the ability to follow up and deliver on agreed actions 

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