Senior Process Engineer, Pto

**THE OPPORTUNITY**
- ** Develop strategies that align **with business imperatives
- ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **top-ranked biopharmaceutical company on the Straits Times **and** Statista’s list of Best Employers in Singapore for two consecutive years (2021, 2022, 2023).**:

- Join the** premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**:

- years.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

**WHAT YOU WILL DO**

The Pharm Tech Operations (PTO) Senior Process Engineer supports/leads the source of supply changes, introduction of new products to the site and/or the transfer of drug products to other facilities either independently or with mínimal support (seeking support/ escalating efficiently where needed). They support/lead all technical/process activities (for example) investigations, validation and qualification processes, risk assessments, process safety management activities under their responsibilities and could be responsible for technical product stewardship activities. They also support continuous process improvement activities to enhance site performance metrics and contributes to the global company technical network to share site experiences/knowledge and continue to expand on personal expertise. They also provide technical supply support on the commercialization and manufacture of all drug products. They support the objectives of his/her seniors/direct supervisor.
- Supports or leads (with mínimal guidance) new product introductions to the site by conducting process and equipment comparisons, new raw materials 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 working knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Demonstrates strength in technical writing for change request, PPQ reports and CMC sections.
- Is involved in and 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.
- Provides technical guidance in support of site and divisional capital projects and new facility start-up activities. Ensures that the process design is well thought-out and robust for routine manufacturing. Provide technical input independently to the process design to ensure its fit for purpose for routine manufacturing. Responsible to transfer the knowledge of the project and facility to IPT colleagues.
- Provides technical expertise 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 expertise for compliance activities such as audit and regulatory support. Monitors and addresses potential regulatory risks during various phases of the lifecycle process independently or as part of a team.
- Supports and manages 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 working knowledge of respective compliance topics related to the above-mentioned activities.
- Supports routine supply manufacture by providing on going technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing company production system tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve 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. This could involve leading/participating in Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance. Where applicable (under the guidance of colleag