Process Engineer

**About the Company
**Job Scope**
- Hand on experiments to establish an auto-production platform, move from the current R&D scale to the manufacturing scale;
- In charge of IOQ, Process validation, and Process transfer, and complete the relevant reports from time to time;
- Supports the 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;
- Establish the manufacturing protocols, reports, and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up, technical transfer, supporting documentation, and compliance the regulatory requirements. Demonstrates strength in technical writing for change requests, PPQ reports, and CMC sections.
- 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 the experiment/evaluation;
- Provides technical guidance to support the site and divisional projects, ensures that the process design is well-thought-out and robust for routine manufacturing;
- Provide technical input independently to the process design, process modification, and scandalization to ensure its fit for purpose for routine manufacturing;
- Provides technical advice related to the product, equipment, and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify the point of occurrence, root cause, and corrective/ preventative actions;
- Help to establish product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g. SOPS, batch records, recipes, reports), 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;
- 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 colleagues if necessary), undertakes responsibilities as an active site product steward;
- Besides, guide in Continued Process Verification and Annual Product review activities as part of product lifecycle management. Applies moderately complex statistical and risk analysis tools to evaluate actions required to ensure product robustness across applicable manufacturing equipment and processes;
- Demonstrates and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are carried out per EHS requirements.

**Requirement**
- Able to multi-task and work under fast-paced enviornment;
- Internship experience in the process engineer role or production roles; Hands-on experience on DCS, and PLC systems will be more prefer;
- Ability to work independently, as well as in teamwork;
- Experienced in pharmaceutical or medical-related manufacturing-related is an added advantage;
- Strong technical, detail orientated, with analytical and problem-solving skills;
- Good communication and excellent interpersonal skills;
- Knowledge of ISO 13485:2016 quality requirements is an advantage but not necessary.

**Job Type**:Full-Time/Permanent