Process & Technology Transfer Engineer Job

Job description

Process & Technology Transfer Engineer-000011ONDescriptionJanssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
For our Pharmaceutical Development and Manufacturing Sciences (PDMS) Department located in Schaffhausen, Switzerland we are looking for aProcess & Technology Transfer EngineerThe PDMS Clinical Supply Chain holds the global responsibility of all clinical supplies of Janssen Research & Development. Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies (API, Drug Product, Packaged Clinical Supplies), through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year.
The Process & Tech Transfer Engineer is responsible for technology and scale-up support to the Pharmaceutical Development and Technical Integrator group as well as to the Clinical Manufacturing in Pilot Plant, External Contract Manufacturing Organizations and Pack & Label activities to provide Drug Product for use in global clinical trials.
The holder of this position will have to pursue an intensive collaboration with: the Pharmaceutical Development and Manufacturing as well as the Pack & Label teams, Technical Integrators, Design Leads and Production Management to ensure production, operation, troubleshooting, non-conformance and change management. The individual will additionally support the Drug Product Development teams with his Process & Facility Engineering expertise and follow up on the progress of the project together with the rest of the Technology Transfer team to assure timely readiness of the installation and equipment at the receiving site.
Further responsibilities include the following:
- Concept, Design, Installation and Implementation of new/modified equipment’s and/or facilities
- Technology transfer support: commercial plant readiness for registration, launch and commercial production, supporting Design of Experiments & scale-up and the follow up of clinical batches at external partners
- optimizations and / or changes to existing equipment
- Setup of the required cross-linked information platforms
- Lead a global project team with members out of different disciplines and with different functions that have their contribution to the project realization
- authoring and review of quality (Trackwise) records
- data analysis from manufacturing IT systemsQualificationsProfilFor this responsible position we are looking for a person with thorough understanding of business requirements and working experience in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines), effective communication, leadership and interdependent partnering skills to be able to build an excellent internal and external network of IT, engineering and development specialists.
The following hard skills are required/ preferred:
- A Bachelor's / Master's degree preferably in Chemical, Mechanical or Pharmaceutical Process Engineering
- Minimum of 10 years related work experience in the pharmaceutical, medical device or consumer product industry
- Knowledge of sterilization technology, parenteral processes, small and large molecules: conventional as well as innovative platforms like lyophilisation, nanomilling and nasal spray
- Expertise in Process Engineering & Scale-up, Pack & Label, Process Analytical Technology and Clinical Manufacturing
- A broad technical background with reference to equipment, IT systems, facilities and utilities (such as electrical, pneumatic, mechanics, HVAC, etc)
- GXP, Regulatory requirements, J&J / JPh-standards & guidelines, applicable Standard Operating Procedures, Engineering Technical Standards, Technical Safety Standards, Industrial Hygiene Standards, MS office applications
- Excellent communication skills in English, both verbal and written, Proficiency in German preferredThis position may require up to 30% domestic or international travel, as needed by business.
We are offering you a multifaceted challenge in a dynamic, international environment with high technology standards, attractive terms and an excellent infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Primary Location:Europe/Middle East/Africa-Switzerland-SchaffhausenOther Locations:Europe/Middle East/AfricaOrganization: Cilag AG (8562)Travel:Yes, 25 % of the TimeJob Function: R&D