Senior Process Engineer USP
Carrières
Supply Chain Engineering
Senior Process Engineer USP
• Titel Senior Process Engineer USP
• Functie Supply Chain Engineering
• Sub functie Process Engineering
• Categorie Experienced Engineer, Process Engineering (ST5)
• Locatie Leiden, South Holland, Netherlands
• Gepost apr 23 2024
• Referentie 2406180182W
Beschrijving
Janssen Biologics B.V., a member of the Johnson & Johnson's Family of Companies is recruiting for a Senior Process Engineer to be based in Leiden, Netherlands! This is a fixed duration role.
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/.
Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products. One of the key focus area's for JNJ in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the Johnson & Johnson site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver better health.
This vacancy is for Business Unit 2: The Gene Therapy Facility (GTF).
Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients?
Then this is your job!
Job Summary:
You will become part of the Process, Technology and Projects (PTP) team and strengthen our department with knowledge and expertise of the Upstream process.
This vacancy is for a Subject Matter Expert (SME) on the Upstream process. You are the process owner and as such have different roles and responsibilities; technology transfers / new product introductions (NPI), base business supporter and project member or - lead.
The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Drug Product, Project management, process excellence and safety. Together, we ensure to have safe, lean, robust, manufacturable, and compliant processes.
Close collaboration within and outside GTF is vital to ensure that the overall GTF goals can be achieved.
The other two departments in the GTF are:
• The Operations Department is responsible for timely, compliant, safe and first-time right manufacturing and delivery of the planned batches
• The system owners in the Center of Expertise (CoE) ensure that our production equipment and single use flow paths in the GTF are operational, safe, compliant, robust and ready for the future.
The departments you work closely with outside GTF are:
• The Gene Therapy development department of Johnson & Johnson is based in the US (Malvern) and responsible for the tech transfer to our site. You will be the main interface and point of contact for them.
• MSAT are the product owners as soon as the product will be commercially manufactured
• MAKE Asset Management (MAM) is responsible for equipment delivery and CAPEX for the tech transfer projects
Key Responsibilities:
The process engineers in the team are process owners and have two major roles:
1. Ensure that new processes and enabling technologies are smoothly implemented into the GTF, using solid project management tools and extensive (bio)technical knowledge. PTP employees are key members or leads during Technology Transfers / New Product Introductions and in projects involving process changes. This involves:
• Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely.
• Ensure that the (development) knowledge is accurately transferred into the process and operational documentation.
2. Support existing processes and technologies by investigating and assessing major process deviations, identifying and implementing process improvements, and analyzing critical process data. During the launch, grow and commercial phases the PTP process engineers are process owners and subject matter experts (SMEs) on the previously introduced processes. This involves:
• Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely.
• Ensure that the (development) knowledge is accurately transferred into the process and operational documentation.
• Support production of cGMP batches for existing processes in the GTF in the area of upstream processing.
• Initiate and handle compliance records (change control, CAPA, deviations), including investigation of major deviations for potential product impact, root cause investigations of complex deviations, evaluation of changes prior to implementation and data gathered post implementation to show that the change had the desired effect.
• have the overview and knowledge of the status of the process.
• Identify, and conceptualize and implement (process) improvements.
• Lead or are key member in projects involving process changes and implementation of (enabling) technologies, including Digital Technologies.
• Are the interface with the product owners (MSAT or R&D), regulatory and value chain departments and work with MAKE Asset Management (MAM).
If you meet the following Job requirements, we would like to hear from YOU:
Kwalificaties
Education:
• Bachelor's degree or equivalent experience is required/ Master's degree in Biotechnology, Biochemistry, Biomedicine, process technology is preferred.
Supply Chain Engineering
Senior Process Engineer USP
• Titel Senior Process Engineer USP
• Functie Supply Chain Engineering
• Sub functie Process Engineering
• Categorie Experienced Engineer, Process Engineering (ST5)
• Locatie Leiden, South Holland, Netherlands
• Gepost apr 23 2024
• Referentie 2406180182W
Beschrijving
Janssen Biologics B.V., a member of the Johnson & Johnson's Family of Companies is recruiting for a Senior Process Engineer to be based in Leiden, Netherlands! This is a fixed duration role.
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/.
Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products. One of the key focus area's for JNJ in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the Johnson & Johnson site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver better health.
This vacancy is for Business Unit 2: The Gene Therapy Facility (GTF).
Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients?
Then this is your job!
Job Summary:
You will become part of the Process, Technology and Projects (PTP) team and strengthen our department with knowledge and expertise of the Upstream process.
This vacancy is for a Subject Matter Expert (SME) on the Upstream process. You are the process owner and as such have different roles and responsibilities; technology transfers / new product introductions (NPI), base business supporter and project member or - lead.
The PTP team consists of 12 professionals with in-depth knowledge of specific subjects such as Upstream processing, Downstream processing, Drug Product, Project management, process excellence and safety. Together, we ensure to have safe, lean, robust, manufacturable, and compliant processes.
Close collaboration within and outside GTF is vital to ensure that the overall GTF goals can be achieved.
The other two departments in the GTF are:
• The Operations Department is responsible for timely, compliant, safe and first-time right manufacturing and delivery of the planned batches
• The system owners in the Center of Expertise (CoE) ensure that our production equipment and single use flow paths in the GTF are operational, safe, compliant, robust and ready for the future.
The departments you work closely with outside GTF are:
• The Gene Therapy development department of Johnson & Johnson is based in the US (Malvern) and responsible for the tech transfer to our site. You will be the main interface and point of contact for them.
• MSAT are the product owners as soon as the product will be commercially manufactured
• MAKE Asset Management (MAM) is responsible for equipment delivery and CAPEX for the tech transfer projects
Key Responsibilities:
The process engineers in the team are process owners and have two major roles:
1. Ensure that new processes and enabling technologies are smoothly implemented into the GTF, using solid project management tools and extensive (bio)technical knowledge. PTP employees are key members or leads during Technology Transfers / New Product Introductions and in projects involving process changes. This involves:
• Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely.
• Ensure that the (development) knowledge is accurately transferred into the process and operational documentation.
2. Support existing processes and technologies by investigating and assessing major process deviations, identifying and implementing process improvements, and analyzing critical process data. During the launch, grow and commercial phases the PTP process engineers are process owners and subject matter experts (SMEs) on the previously introduced processes. This involves:
• Ensure that the implemented process is well defined and aligned with the operational procedures. For new processes it means that the (small scale) developed process needs to be evaluated and the changes required within the GTF for the robust and compliant implementation of a manufacturable process are defined precisely.
• Ensure that the (development) knowledge is accurately transferred into the process and operational documentation.
• Support production of cGMP batches for existing processes in the GTF in the area of upstream processing.
• Initiate and handle compliance records (change control, CAPA, deviations), including investigation of major deviations for potential product impact, root cause investigations of complex deviations, evaluation of changes prior to implementation and data gathered post implementation to show that the change had the desired effect.
• have the overview and knowledge of the status of the process.
• Identify, and conceptualize and implement (process) improvements.
• Lead or are key member in projects involving process changes and implementation of (enabling) technologies, including Digital Technologies.
• Are the interface with the product owners (MSAT or R&D), regulatory and value chain departments and work with MAKE Asset Management (MAM).
If you meet the following Job requirements, we would like to hear from YOU:
Kwalificaties
Education:
• Bachelor's degree or equivalent experience is required/ Master's degree in Biotechnology, Biochemistry, Biomedicine, process technology is preferred.
Mis geen nieuwe vacatures!
Meld u nu aan en ontvang de nieuwste Process Engineer vacatures in Leiden
Het is gratis en je kunt e-mailupdates op elk moment uitschakelen