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  • Job title:

    Manufacturing Process Engineer

  • Sector:

    Biotechnology, Pharmaceutical

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 Manufacturing Process Engineer

As Manufacturing Process Engineer, you’ll be joining a team, in which employees of all backgrounds and experiences are respected, and were working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting to the (Senior) Manager Manufacturing Technical Services (MTS).

You’ll be part of the MTS team for our recently established manufacturing site in Hoofddorp (NL). In this role you will be part of the technical team, responsible for manufacturing technical training, front-line support, root-cause investigations, continuous improvement, and projects for Kite’s commercial manufacturing site producing autologous T-cell therapy products.

The role focuses on the upcoming replacement of our Oracle ERP system with SAP S/4 HANA and its implementation at the Manufacturing department. Manufacturing will use SAP for the following business processes:

- Batch management (incl. resourcing and cost)

- Inventory Management

-  Chain of Custody/Identity management 

The project will be divided in five phases: Design Deep Dive, Realize – Build, Data Conversion, Realize – Test and Cut-over planning and go-live.

Your responsibilities

You will have different responsibilities during the different phases of the project:

Design Deep Dive:

• Process mapping of Manufacturing SAP related business processes

• Ensure that manufacturing business requirements are captured in the design workshops for SAP

• Participate in the redesign of business processes in case SAP would need unjustifiable customization

• Stay aligned with internal Manufacturing stakeholders to ensure SAP design reflects the need for the shop floor

• Engage with interfacing departments/systems to ensure hand-over requirements are captured (e.g. warehousing department or MES system)

Realize - Build:

• Participate in discussions with the SAP design team on the solutions being created

• Socialize partial builds early on with shop floor to increase shop floor engagement

• Course-correct if needed

Data Conversion:

• Participate in transfer and validation of Manufacturing Master Data

• Participate in the validation of Master Data.

Realize – Test

• Test final SAP functionality

• Involve Manufacturing Shop Floor to ensure SAP supports the shop floor operation in the most efficient way possible

• Conducts technical training and guidance to the Cell Therapy Specialists/operators

Cutover Planning and Go-live:

• Conducts technical training and guidance to the Cell Therapy Specialists/operators

• Provide front line technical support during go-live

• Hand-over/cross-training of all relevant material to the business

Your profile

• Bachelor’s degree or equivalent experience.

• 3-5 years’ relevant (operator/process engineer) experience within a Pharmaceutical/GMP Manufacturing Site.

• Experience with SAP introduction/implementation in a manufacturing environment

• Excellent knowledge of manufacturing processes

• Good experience with supporting users

• Good experience in delivering training including classroom - and on the job training.

• Experience with writing and execution CSV documentation / protocols

• Experience in identifying opportunities for improvement, best practice, and standardization.

• Experience with GMP in a pharmaceutical environment, preferable cell therapy

• Knowledge of SAP S/4 HANA

• Good interpersonal skills.

Personal skills

• Comfortable in a fast-paced expanding company environment and able to adjust workload based upon changing priorities.

• Ability to function efficiently and independently in a changing environment

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

• Collaborate well in cross-functional matrix environment, ability to communicate and work independently with scientific/technical personnel.

• Ability to think critically and demonstrated troubleshooting and problem-solving skills.

• Good English language skills.

Additional Requirements

- Willingness to work shifted hours. SAP is being implemented for all Gilead/Kite sites. Therefore, design workshops and other activities can take place in the evening for the GMT+01 time-zone.

- On-site presence is needed depending on the phase of the project. Training is preferably done face-to-face. Design workshops are remote due to their international nature.