Technical Support Scientist
il y a 2 semaines
**Function**
**(Based in Leuven HQ with Home office and regular sites visits)
The Technical Services Scientist function reports to Director of validations and provides Expert Advisory Services (EAS) support to the facilities.
The position requires periodic association with Corporate Management, including Quality Management, Laboratory groups, Manufacturing and Engineering, Regulatory Affairs, Information Technology and Marketing.
- Travel will be required
- Home office or facility based as agreed with Management Support for R&D New Technologies**Responsibilities
The Technical Services Scientist is responsible for the following:
- The primary responsible for implementing and maintaining up to date datalogger technology associated with client product validations and plant equipment qualifications.
- Managing datalogger software and the datalogger calibrator program complying to in-house specifications or to coordinated vendor service as required.
- Supervising training of the facility validation staff for data logger use and calibration verifications.
- Problem solving for validation related questions and challenges.
- Assistance with developing and executing the internal training program to the validation teams. Mentoring facility validation staff as and when required.
- Global travel when necessary to assist facilities, corporate initiatives, and clients.
- Performing and coordinating designed experimentation, process definition studies, equipment capability analysis, correlation studies, trend analysis, repeatability, and reproducibility studies to further develop and enhance sterilization processes.
- To have the ability to plan, organize and effectively manage their project activities as per the Sterigenics Quality Management System.
- Analyzes, diagnoses, and recommends improvements to sterilization processes by:
- Assisting in failure investigations and root cause analysis
- Recommending preventative and corrective actions
- Assists clients and facilities with scientifically based analysis of processes.
- To follow appropriate external regulatory standards plus internal procedures for their technical and engineering studies.
- To handle engineering projects in the pursuit of evaluating new technology, process improvement and associated testing.
- Assists when required in development of computer programs to enhance the analysis of problems and processes.
Budget and monitor the costs associated with projects as quoted and inform Supervisor when quote amount is exceeded**Experience (Skills, Knowledge, and Abilities)
- Technical Support is best served by a technically oriented individual with a knowledge of Engineering, Physics, Chemistry and Microbiology.
- Technical Support requires a knowledge of statistical methods for analysis including, correlation, capability analysis, linear regression, and cause and effect analysis. A working knowledge of the physics relating to the sterilization process is necessary.
- Technical Support should have knowledge of FDA regulations, applicable microbiological concepts, and ISO sterilization requirements.
- To accomplish the goals of the position, it requires the ability to communicate technical information effectively in English.
- The position requires the ability to operate a personal computer with Microsoft Office and other software packages as necessary.
- Must be medically approved for respirator use and able to tolerate exposure to high temperatures and humidity (120 degrees F and 60% RH for 20 minutes). Must be able to lift a minimum of 50 pounds.**Education/License/Technical Requirements**
- Bachelor Degree or Master Degree in a science related discipline, or equivalent years of relevant experience.
- At a minimum the individual must have a bachelor’s degree in Engineering, Physics, Microbiology, or technical equivalent, with classes in Statistical Analysis and Chemistry.
- The position requires 5+ years’ experience with industrial experience in either sterilization or another related field.
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