Senior Technical Transfer Engineer
- Engineering, Operations & Maintenance, Quality Assurance
- Netherlands, Netherlands
- Fulltime
- per month
Senior Technical Transfer Engineer (Drug Substance) – External Manufacturing – Technical Operations
Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is responsible for technology transfers and the commercial production of Biological Drug Substance at our External Partners (EPs). This person will have the opportunity to participate in various areas, including supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and optimizing process and capacity.
Responsibilities :
Collaborate with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients.Oversee technical activities for the commercial manufacturing process at the External Partner, including authorship of change controls, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.Manage technical transfer activities through authorship and / or review of required GMP documentation (Master Batch Records, change controls, protocols, reports, qualifications, etc.) and regulatory filings.Provide on-site support at External Partners for Commercial and / or Technology Transfer Person-In-Plant Activities.Translate GMP requirements and current regulations into standardized work practices in collaboration with Operations, Quality, and External Partners.Ensure External Partners are inspection-ready for all routine inspections and inspections related to new product introductions or transfers, in cooperation with Operations, Quality, and Regulatory teams.Participate in creating, sharing, and adopting best practices and business process strategies.Education Minimum Requirement :
Bachelor’s degree in Chemical / Biochemical Engineering, Pharmaceutical Science, Chemistry / Biology, or another related science or engineering field.Required Experience and Skills :
Minimum of 4 years post-bachelor’s degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and / or Maintenance.Willingness to travel approximately 25% of the time.Strong communication skills in English and effective teamwork abilities.Preferred Experience and Skills :
Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer.Demonstrated ability to independently manage projects and meet schedules / deadlines.Experience with statistics (including Proactive Process Analysis and Continuous Process Verification).Experience in deviation management, change control, equipment support, and / or project management.Dutch language skills are not required.This position is primarily home-based.