Process Engineer

**Job Title: Process Engineer / Senior Process Engineer (Drug Substance)**
**Location: Singapore**

**About the role**:

- Responsible for planning and supporting the Dengue Drug Substance Process Technology Transfer from Takeda to Contract Manufacturing Organization (CMO) in India. Includes document/knowledge transfer activities, process design and improvements, process scale-up, GMP Production, and validation aspect of the manufacturing.
- Involved in developing Technical Operations documents, including the establishment Technology Transfer Protocols, Risk Assessment, Comparability protocols, etc, in support of the main Technology Transfer activity.
- Review of CMOs documents such as Studies protocol, SOPs, Batch Records, Deviation and Change Control, etc.
- Close Collaboration with internal and external stakeholders to ensure projects are conducted to an appropriate standard and in timely manner.

**How you will contribute**:

- Overseeing Takeda Drug Substance manufacturing activities at the CMO, acting as Person-In-Plant, as process owner in the CMO facility.
- Responsible for ownership and completion of Batch Record / Study Reports review, Change Controls, investigations, and CAPAs arising from manufacturing runs executed at CMO.
- Participate in the Technical discussions and activities with global team for Takeda’s Vaccines Drug Substances Transfer to CMOs.

**What you bring to Takeda**:
Education and Experience Requirements / Key Skills and Competencies:

- Bachelor degree (with relevant experience) or MSc in life sciences or closely related field, at least 2 years of applicable experience (4 years for senior position).
- Experience in Biologics process (Drug Substance) development and/or manufacturing environment is required. Knowledge in vaccines manufacturing process would be an advantage.
- Experience in Cell Culture (Attachment Cell lines) would also be an advantage.
- A thorough knowledge and experience of Good Documentation Practices (cGDP) and cGMP.
- Experience in writing/review/approval of technical documents, including validation documents, Risk Assessment, protocols and reports, etc.
- Experience in Validation strategy and implementation in GMP manufacturing facilities.
- Familiar with Quality Management System aspect/implementation in Manufacturing Facility.
- Well organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
- Knowledge of statistical analysis for biological systems (non-clinical stats) and Design of Experiments (DoE) as applied in an industrial biopharmaceutical environment will be a distinct advantage
- Team player with strong initiative & drive
- Strong verbal and written communication skills, diplomacy and positive influencing abilities
- Comply with Takeda safety practices and standard operating procedures.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:

- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time