Process Engineer Ii

**Job Title: Process Engineer II**

**Location: Woodlands, Singapore**

**Reporting to : Process Engineering Manager**

**About the role**:

- Process engineer II coordinates improvements and change controls associated with designated systems (coordinates with Plant & automation engineering along with manufacturing and MS team).
- Process Engineer II Evaluate the ongoing performance of the designated process systems with respect to their overall performance, yield/output and efficiency and make the necessary improvements where deemed appropriate.

**How you will contribute**:

- Ensures that the system in its totality (hardware, controls, sequence of operation) are fit-for-purpose and aligned with the business needs
- Support/Lead for the timing and strategy of process improvements and change controls
- Lead Quality Event (Deviation) process for Process Engineering and ensure timely creation, analysis and closure of events.
- Lead Change Control for Process Engineering and ensure timely creation, implementation and closure
- Responsible for Functional Specification Management.
- Provide support for weekly Plant Change Management meeting.
- Participate as Process Engineering representative on cross functional support team meetings.
- Primary liaison for engineering for RCAs and investigations (pulls in Process System & automation engineering as appropriate)
- Responsible for process safety assessments and hazard identification.
- Primary liaison for engineering for process FMEAs. Defines equipment operating ranges and ensures is aligned with process / product need
- Liaise with global engineering function to provide feedback on proposed and existing engineering standards and implement these as appropriate within the facility
- Target Delivery of results right first time
- Trouble shoots and resolves technical equipment problems and takes corrective action
- Timely closure of EHS and Quality event investigation and corrective & preventive action tasks.
- Lead CAPEX Project for Process Engineering and ensure timely implementation and closure
- Provide support for project teams for any new projects, makes recommendations based on experience
- Provide support for the evaluation and assist in the implementation of new technology for process execution and/or analysis
- Completes all required documentation for proper traceability complying with Takeda requirements
- Provide training to the end user on relevant technical aspects of installed plant assets
- 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/Bio/Process/Mechanical engineering discipline
- Minimum 4 years of process engineering experience in Biologics, Pharmaceuticals and/or similar manufacturing industries
- Experience in bio-processing engineering in a manufacturing environment is highly desirable
- Knowledge of unit operations associated with cell culture and downstream processing including: media and buffer preparation, bioreactors, depth filtration, sterile filtration, single-use technologies and chromatography skids & columns
- Experience in the design and operation of biopharmaceutical manufacturing equipment and
facilities.
- Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines
- Experience in a GMP environment is preferred
- Management experience within a multi-disciplinary team is an added advantage

**Key Skills and Competencies**
- Excellent process and equipment knowledge of biological drug substance manufacturing processes; upstream /downstream unit operations expertise highly preferable
- Knowledge/ Experience in DCS, PLC, OSIPI and Electronic Batch Management systems is an added advantage
- Ability to effectively communicate via writing and oral communication at all levels.
- Express ideas effectively in individual and group situations (including non-verbal communication).
- Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people.
- A good understanding of design principles and standards within the biopharmaceutical facilities.
- Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts
- Demonstrated ability to lead technical projects from concept through implementation, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
- Supervision of contractors and trade workers is required during execution of projects.
- Ability to understand and challenge design and execution concepts from outside vendors/engineers.
- Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles