Process Engineer

Optimize chemical processes of product campaigns (Projects) within the Pharmaceutical Fine Chemical Business to enable the production department to deliver services according the supply agreement and to increase company profit.

Function

1) Support the introduction of new technical processes

• Organise the Technology Transfer Process to production
• Lead the process engineering and participate in the process safety and environmental risk assessments
• Review of Master Batch records (MBR), process validations & homogeneity studies
• Prepare the production campaigns with the project team and chair the team meetings
• Accommodating customer process witnessing in production

2) Improve technical processes in repeated product campaigns to optimize cost and to ensure right first time

• Improve process performance by initiating process optimizations through monitoring, statistical data evaluation (CPV studies) and technical process advice
• Carry out feasibility studies and impact assessments in case of process changes
• Document Planned Changes (PCR) and support adaptation of Master Batch Records
• Follow up of deviations (UCR), Out-Of-Specifications (OOS), Confirmed Atypical Results (CARI): investigate, coordinate and document root cause analyses, review corresponding documentation and support implementation of corrective and preventive actions
• Technical troubleshooting while witnessing the process

3) After campaign review

Review and analyse product campaign and inform all stakeholders in an uniform and transparent way

4) Become a process expert by keeping up to date with the state-of-the art technology trends and developing an in depth knowledge of the assigned in-company processes

5) Build and maintain strong collaboration with internal stakeholders to create a fluent team interaction and progress of the project

Profile

• You have a Master degree in Chemistry, (Bio)engineering or equivalent
• Strong chemical and process technical competencies
• 5 years experience in a production environment, preferably in pharmaceuticals
• Knowledge of GMP, process risk analysis and process validation
• Excellent communication skills in Dutch and English
• Team player able to work with different stakeholders and skilled in chairing project team meetings
• Pursue ‘first time right’ attitude
• Pro-active way of working
• Excellent planning and organising skills
• Capacity to cope with pressure