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Description:

Manufacturing Process Engineer – MES specialist

Our client is at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As Manufacturing Process Engineer, you’ll be joining a team, in which employees of all backgrounds and experiences are respected, and where 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 commercial manufacturing site producing autologous T-cell therapy products. The role focuses on MES but also has to opportunity to take part in other process engineering activities.

Your responsibilities

General process engineering:
• Conducts technical training and guidance to the Cell Therapy Specialists
• Provide front line technical support for manufacturing of cell therapy products
• Implement improvements and participate in projects
• Participates in internal audit/inspection

MES specialism:

MES EBR editor
• Understand the process and user requirements driven by process maps / flows in preparation for developing or updating MBR designs.
• Convert process and user requirements into specific MBR designs and design elements (Basic Functions, Basic Operations, complex Formulas and ERP integration)
• Drive and support MBR design verification activities (lifecycle documentation generation, configuration/design testing and qualification)
• Manage MBR approval and retirement workflows to ensure correct record state.
• Generate and maintain system life cycle documentation such as User Requirements Specifications, Configuration Specifications, and Functional/Design Specifications.
• Lead design reviews with peers and cross-functional stakeholder team.

MES Key user
• Serve as part of level 1 support group for MES users by analyzing and resolving issues and providing necessary instructions.
• Escalate business continuity impacting issues to Process Owner and level 2.
• Support MBR impact assessments based on the manufacturing/business process requirements and changes.
• Identify and document MES (business) and manufacturing process requirements.
• Identify and document improvement proposals.
• Support Training materials development.
• Provide/Support user training
• Create and update Process SOPs, MES SOPs, and MES work instructions
• Provide input during design reviews of new and updated MBRs
• Provide input for lifecycle documentation generation and updates.
• Support testing and qualification activities
• Keep knowledge up to date with MES application.


Your profile

Education
• Bachelor’s degree or equivalent experience.

Knowledge and Experience
• 2-3 years’ relevant (operator/process engineer) experience within a Pharmaceutical/GMP Manufacturing Site.
• 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 PAS-X version 3 is preferred
• Experience with SQL and XML coding with respect to MES is a plus
• Knowledge of the MES database and data elements as part of querying and reporting is a plus
• 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
• Able to work in shifts including weekend shifts and/or be able to work on-Call / On stand-by outside office hours