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Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Senior Sterilization Validation Engineer (m/f/d)

Johnson & Johnson Innovative Medicine is recruiting for a Senior Sterilization Validation Engineer within Manufacturing Science And Technology (MSAT), located in Beerse, Belgium.

A MSAT Sterilization Validation Engineer is a member of the MSAT Life-Cycle Management Validation team. This team has a passion for sterility processes and works together with operations and quality to deliver safe and quality products to our patients. Within this team process improvements and innovation are an important focus. By working in a pharmaceutical environment, you can have direct impact on the lives of our patients!

Key Responsibilities

• Subject Matter Expert (SME) for sterilization validations processes (such as thermal, dry heat, gamma irradiation, VHP decontamination, APS) and sterilization/aseptic manufacturing systems such as autoclaves, SIP systems, isolators.

• Manage and execute Validation Master Plan (VMP) and coordinate the Validation Master Planning.

• Continuously focussing on safety, quality, GMP and operational discipline while ensuring contemporary validation standards are followed.

• Participate in system and process improvements and optimization processes.
   

Qualifications: Education

• Master’s Degree in Engineering or Science or equivalent.

• Other relevant fields of study are accepted and will be considered.
   

Experience and Skills

• Minimum 3 to 5 years of relevant experience in a pharma/life sciences environment.

• Expertise on pharmaceutical manufacturing processes & products and/or equipment & facility engineering (if applicable) especially for the involved technology platform.

• Experience in at least one of the following functions: clinical supply chain, commercial supply chain, or in a support role for sterilization validation engineering.
   

Required

• Strong interest in working in a pharmaceutical environment with a focus on sterilization validation processes

• Team player with a can-do mentality

• Ability to be a key team member in business-critical projects

• Ability to work independently and manage complex issues and changes in a problem-solving manner

• Ability to connect globally within J&J with SME of other sites

• Ability to act as a spokesperson during audits
   

Preferred

• Expertise in aseptic manufacturing

• Knowledge of international regulations, guidelines and industry practices related to sterilization validation

• Knowledge and interest in statistics and multi variate analysis

• Proficiency in Dutch, as interaction with our operators in the supply chain is required. Fluent in written and spoken English

• Certification or training as an FPX project manager
   

 

 

Required Skills:

 

 

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection