Job Description - Experienced Sterilization Validation Engineer MSAT (2506231899W)
Johnson & Johnson Innovative Medicine is recruiting for an Experienced Sterilization Validation Engineer within Manufacturing Sciences And Technology (MSAT), located in Beerse, Belgium.
A MSAT Sterilization Validation Engineer is a member of the MSAT Sterilization 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 a 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, isolators.
* Manage and execute Validation Master Plan (VMP) and coordinate the Validation Master Planning.
* Key contributor to New Product Introductions (NPI) & New Equipment Introductions.
* Continuously focusing 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 2 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, logistics, 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 multivariate 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.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
At Johnson & Johnson, we all belong.
Primary Location
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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