Process Engineer

**JOB PURPOSE**

The PTO Process Engineer provides technical supply support on the commercialization and manufacture of all drug products with mínimal support from seniors or direct supervisor (seeking support/ escalating efficiently where needed).. He/ she supports all technical/ process activities (for example) investigations, validation and qualification processes, risk assessments and process safety management activities under his/ her responsibilities. The PTO Process Engineer also supports continuous process improvement activities to enhance site performance metrics and contributes to the global technical network to share site experiences/ knowledge and continuously expands on personal expertise. He/ she also supports the introduction of new products to the site and the transfer of drug products to other facilities. The PTO Process Engineer supports the objectives of his/her seniors and direct supervisor.

**MAIN RESPONSBILITIES**

Supports new product introductions to the site by supporting and/or conducting process and equipment comparisons, new raw material introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have a basic knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements.

Demonstrates ability in technical writing for investigations, change request, PPQ reports and CMC sections.

Is involved in/ supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for products/ processes to evaluate the impact of proposed changes to validated equipment/ processes. Proactively identify solutions with support from seniors or direct supervisor to address issues that arose during experiment/evaluation

Supports site and divisional capital projects and new facility start-up activities if applicable. Provide technical input to the process design to ensure its fit for purpose for routine manufacturing in collaboration/ support from colleagues. Responsible to transfer the knowledge of the project and facility to IPT colleagues

Provides technical support related to the product, equipment and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventative actions.

Provides technical support for compliance activities such as audit and regulatory support. Collects data and documents to be presented to regulators during site inspections and for regulatory submissions.

Demonstrates an understanding of the manufacturing lifecycle of a product including technical requirements, analytical regulatory guidelines/ expectations associated with global regulatory submissions.

Supports product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g. SOPs, batchsheets, recipes), quality risk assessments, change control management/ filing support (if applicable) and validation activities such as equipment qualification, simple process validation and cleaning validation/monitoring activities. Expected to have a basic knowledge of respective compliance topics related to the above-mentioned activities and Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.

Supports routine supply manufacture by providing ongoing technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing Production Systems tools. Supports the activities to ensure optimum production runs, constraints and non-conformances identification and troubleshoots to resolve basic issues in production systems.

Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. Participates in

Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance.

In addition, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management.

Demonstrates basic knowledge of statistical and risk analysis tools to identify action required to ensure product robustness across various types of manufacturing equipment and processes.

Demonstrates understanding of product CPP, CQA, Cpk and (where applicable) sterile boundary of the current validated processes. Familiar with raw materials and PCC (product contact components) used for the products under his/her responsibility.

Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. Participates in Prospective Proces