Senior Engineer, Pharmaceutical Technical

**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 (2020, 2021).**:

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

The PTO Senior Process Engineer/ Chemist provides technical supply support on the commercialization and manufacture of all drug products 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 his/ her 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 continuously expands on personal expertise. They also support/lead the introduction of new products to the site and the transfer of drug products to other facilities. They support the objectives of his/her seniors/ direct supervisor.

**What you will do**

**Critical Responsibilities but not limited to**:

- 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, batch sheets, 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 and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.
- Supports routine supply manufacture by providing on going technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing Production Systems 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 colleagues if necessary), undertakes responsibilities as an active site product steward and is a member of the Value Chain Technical Team.
In addition, participates 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 good understanding of product CPP, CQA, Cpk and sterile boundary of the current validated processes. Have good knowledge of the raw materials and PCC (product contact components) used for the products under his/her responsibility.
- Demonstrates leadership behaviors in alignment with company leadership standards
- Any other duties as assigned by the Supervisor.
**What you must have**:
To be successful in this role, you will have:

- Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences.
- 3 to 5 years technical experience in pharmaceutical, oil and gas or semiconductor industries.
**WHAT YOU CAN EXPECT**
- Limitless opportunities across various areas in Manufacturing; well-structured career path
- A state-of-the-art facility that delivers solution