Responsible for assuring smooth handover of projects into the on-site activities executed by the local service teams. Ensuring project system serviceability after system acceptance, and elevated level of service support function during Hypercare periods (first months of system operation by customer after acceptance).
Responsible for assuring smooth handover of projects into the on-site activities executed by the local service teams. Ensuring project system serviceability after system acceptance, and elevated level of service support function during Hypercare periods (first months of system operation by customer after acceptance). Interacting with the project management/engineering teams during the following stages of the project with respective responsibilities:
Tasks in project design/engineering
- Review system design together with the service concept team to confirm system serviceability, or define service processes for novel components (spare parts list, calibration points, 3D design review for accessibility, etc.)
- Transmit information to service technical documentation team.
Tasks in system buildup/commissioning
- Review the procedure and collect specific information for the following related processes;
- System assembly and utility hookup
- Check of mechanical and electrical completeness; deviations to be proactively communicated to PM
- System start up in collaboration with automation engineer
- Parameterization of the automation system (controller and hardware) or verification of the parameterization; all hardware parameter settings to be documented with the project parameter list
- Execution of commissioning according to manufacturer test protocol
- Handover of Serial Number List incl. all remaining certificates and to SQD
- Verify correct closure or at least establishment of action plans for any open items after commissioning.
- Transmit information to respective local service teams.
Tasks in FAT
- Same as with system buildup/commissioning, but for the following processes;
- Organization of FAT test execution according to the test plan and QTR
- List up of required consumables for test execution (to be used as reference for SAT)
- Execution and documentation of installation and operational tests according to the test plan and QTR
- Note of customer wishes, proposals for improvements etc. and communication to the project manager
- Confirm FAT completion (all tests done acc. to QTR, all deviations closed)
- Preparation for shipment according to check list and hand over to SCM
- Verify correct closure or at least establishment of action plans for any open items after FAT.
- Transmit information to respective local service teams, to prepare for SAT execution.
Tasks on-site
- Responsibility of Forman Function for installation, and commissioning.
- Daily team briefing with assigned customer site manager with dedicated local team every morning.
- Basic safety standards of dedicated project test area (cable routings, electrical safety, etc.)
- Organization of dedicated project area (no rubbish, clean desks, 5S rules to be applied as far as possible)
- Daily progress check and reporting (fill progress data into QTR), deviations to be actively informed to PM
- Daily check for sufficient capacities; necessary adjustments to be proactively communicated with team lead.
- Responsibility as Technical advisor in SAT;
- Preparation of onsite activities (e.g., shipment of test equipment, consumables, etc.)
- Confirm availability of process equipment, test references, software etc. “ready for SAT”
- Organization of SAT test execution according to the test plan and QTR
- Train customer and local service on documentation understanding, and system operation
- Oversee execution and documentation of tests by local service team according to the test plan and QTR
- Daily progress check and reporting (fill progress data into QTR)
- Note of customer wishes, proposals for improvements etc. and communication to PM
- Verify correct closure or at least establishment of action plans for any open items after FAT with PM
Individual orders:
In addition to the listed tasks above, the employee is obliged to carry out individual orders as instructed by the supervisor, which essentially meets his / her duties and capabilities or results from the operational needs. Participation in the optimization of internal processes to improve our quality, health and safety standards. Contribution in the ongoing improvement and revision process of the qualification strategies and the basic qualification documents.
Qualification & Skills:
- Your university degree in the field of process engineering, biotechnology, automation technology or a comparable training with several years of professional experience in the pharmaceutical environment
- You have relevant professional experience in the areas of commissioning or system qualification in the pharmaceutical industry.
- You can demonstrate well-founded GMP | GDP knowledge and knowledge of relevant guidelines and standards in the pharmaceutical sector.
- Desirably, you are familiar with the IQ | qualification steps DQ | OQ | PQ
- Experience in delivering service / user training to groups of various sizes in person.
- A very high-quality awareness, assertiveness, flexibility and a pronounced customer orientation round off your profile.
- Experience of systems used in similar bioprocess applications is highly desirable.
- We require very good written and spoken English as well as willingness to travel Locally/Internationally (around 50%)
- Effective customer facing skills.
- Ability to manage meetings effectively.
- Strong, effective communication skills
- Team player
- It is important to identify with our corporate values: sustainability, openness, joy
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers
Similar Jobs
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.
The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.
Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
