Manufacturing Expert

**Job Title: Manufacturing Expert**
**Location: Woodlands, Singapore**

**About the role**:

- With some supervision, the individual will support and coordinate routine GMP manufacturing life cycle and day to day operational activities associated with the products and process equipment in Takeda Singapore, including but not limited to Manufacturing Suite 1, Manufacturing Suite 2 and Manufacturing Support areas. In addition, the individual will provide critical ad hoc support to continuous improvement, validation and CAPEX activities.

**How you will contribute**:
The individual will support the EHS and cGMP compliance of day to day and tactical manufacturing activities and ensuring production activities are executed successfully. Primary responsibilities include: (70%)
- Work hand-in-hand with the shift teams to ensure adherence to the production plan, resolve issues, as required.
- Be considered to have more than one area of manufacturing expertise, for example, Upstream processing/Downstream processing/ Equipment Preparation/ Buffer Preparation and/or knowledge in key systems like EBM/XFP/CIP/SIP knowledge.
- Carry out deviations investigations in the GEMS system, including product impact assessments and implement CAPAs.
- Be a change control owner in the CCMS system, if applicable
- Coordination of daily activities between shift teams and supporting functions
- Maintain recipe configuration management documentation, if applicable
- Carry out material support activities including liaising with MLCM or vendors to address material issues, if applicable
- Actively support the transfer of new processes and commissioning & validation activities of new projects, if applicable
- Informing management of events impacting production schedule
- Propose and review document revisions.
- Carry out work in a safe manner, notifying management of safety issues and risks
- Provide documentation support to Manufacturing, including document archival.
Provide administrative support to Manufacturing Standalone equipment, including system maintenance and data integrity management.

The individual will manage equipment and support facility related projects by: (20%)
- Able to lead investigations with the support of Operational Excellence or other functions.
- Contribute to continuous improvement.
- Able to lead investigations with the support of Operational Excellence or other functions.
- Contribute to continuous improvement

Staff Technical Training and Development: (10%)
- Meet and maintain training requirements on time.
- Provide technical training for shift personnel, as required.
- Develop training material, as required.
- Develop and maintain personal development plans.
- Participate in site or global strategic initiatives, as required.
- Provide feedback to peers to help staff development, as required.
- Provide annual performance self-assessment on development plan

Others:

- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.

**What you bring to Takeda**:
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or related and possesses 0 - 2 years of relevant experience in the biotechnology or pharmaceutical industry.
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or related and possess 2 - 4 years of relevant experience in the biotechnology or pharmaceutical industry.
- Nitec in Biotechnology / Chemical Process Technology or related with 4 - 6 years of relevant experience in the biotechnology, pharmaceutical industry.
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Able to work on odd hours as required

Key Skills and Competencies

The individual should have good understanding of cGMP manufacturing aspects and had hands-on manufacturing experience.
- Proficient at technical writing as required for Electronic Batch Management (EBM), Batch Records (MBRs, MFRs) and Standard Operating Procedures (SOPs).
- Possess good communication and presentation skills.
- Possess good troubleshooting skills and critical thinking.
- Full awareness of current Good Manufacturing Practices (cGMP)
- Proficient documentation skills and computer skills including Microsoft Excel/Word/PowerPoint
- Good time management skills
- Ability to work in a matrix environment.
- Understanding of requirements from support functions and their capabilities
- Experience as a system user of business systems such as C3ME, XFP and Trackwise
- Will work holidays and overtime as required.
- May be