Process Engineer II (Process Engineering)

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Job Description

Takeda's Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia.  The facility has two buildings, including manufacturing suites and laboratories, as well as Takeda’s first positive energy building certified by Singapore’s Building and Construction Authority’s Green Mark scheme in 2022.

Job Title: Process Engineer II (Process Engineering)
Location: Woodlands, Singapore

About the role:

• The Process Engineer II is recognized within Takeda as technical subject matter expert (SME) for designated systems for the Singapore Biologics Manufacturing facility from an equipment capability perspective. In this role, he/she is responsible for all process engineering activities within the Site engineering function. This position reports into the Process Engineering Manager.
• 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.
• Ability to look at plant problems and come up with options for solutions.
• Gain approval for recommended solution and implement through proper channels.
• Provides solutions to a wide range of difficult problems; solutions are imaginative, thorough and practicable.
• Ability to work effectively with internal and external teams or those outside formal line of authority (e.g. peers, senior managers) to accomplish goals.

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.

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