Company Profile:
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.
About the role:
- Process Systems Engineer II is recognized within Takeda as technical subject matter expert (SME) for designated systems for the Singapore Biologics Manufacturing facility from a systems perspective.
- Process Systems engineer II is an integral member of the Singapore Process Engineering Team, he/she reports into the Process Systems Engineering Lead/Process Engineering Manager.
- Process Systems engineer II interacts closely with the Manufacturing supervisors to ensure that all Systems engineering activities are delivered to support reliable and robust manufacturing operations.
- Process Systems engineer II will be part of Process engineering organization focusing on Right First Time delivery and following industry best practices to meet the strategic needs of the Takeda Singapore Manufacturing Facility.
- Process Systems engineer II support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements. This work includes preparation of scope of work documents, cost estimates, and project schedules.
How you will contribute:
- Act as system technical owner for Upstream, Downstream equipment’s and other unit operations and acting as primary engineering liaison between the system business owner and engineering.
- Lead the engineering remediation activities on designated systems (Deviations, complex Corrective Maintenance, hardware fault finding) which include generating necessary RA, Job Plans together with Engineering Operations.
- Lead Quality Event (Deviation) process and ensure timely creation, analysis and closure of events
- Lead engineering change controls to completion for designated systems.
- Provide troubleshooting support for manufacturing operations especially with regards to equipment issues
- Troubleshoot and fault find equipment’s which are not operating to expected parameters when identified and post preliminary troubleshooting by Engineering Operations
- Identify deficiencies and/or improvements in existing PMs and advise reliability engineering of same. Escalate issues to Process Engineering Lead/Manager as appropriate following initial troubleshooting if issues cannot be resolved
- Proficiency with troubleshooting of complex equipment and performing formal root cause analysis investigations.
- Own and implement projects (CAPEX/AIMP) to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, request from value stream stakeholders or GMP audits.
- Timely closure of EHS and Quality event investigation and corrective & preventive action tasks.
- Create Corrective Maintenance job plans in CMMS and change controls as needed for complex CM that has potential quality/product impact.
- Review standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists
- Identify and assist in procurement of spare parts required for process equipment maintenance activities.
- Participate as Process Engineering representative on cross functional support team meetings.
- Execution of activities like RV(Receipt Verification), hardware FAT/SAT & installation verification associated with equipment changes and new equipment installations.
- Review vendor turnover package documentation to ensure it meets all requirements
- Ensure materials of construction of manufacturing equipment’s are appropriate to meet process requirements.
- Manage construction activities associated with implementation of engineering projects, if required.
- Perform detailed technical designs for new equipment or changes to existing equipment through an understanding of user requirements and completion of design reviews with project stakeholders.
- Assist Validation team with execution of qualification protocols including IQ, OQ, and PQ
- 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 Mechanical/Chemical engineering or equivalent Engineering Discipline with minimum 3 years of experience is required.
- Diploma in Mechanical/Chemical engineering or equivalent Engineering Discipline with >5 years of experience is required.
- Experience in an engineering role supporting cGMP operations in a pharmaceutical/biopharmaceutical manufacturing plant is required.
- Demonstrated mastery of technical drawings including PFDs, P&IDs, general arrangement drawings, and equipment design drawings is required.
- 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.
- Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
- Knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
- Willing to be scheduled for call-outs during non-office hours to support manufacturing emergencies
- Experience in bio-processing engineering in a manufacturing environment is highly desirable
Key Skills and Competencies
- 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.
- Take actions that respect the needs and contributions of others; contributing to and accepting the consensus; subordinating own objectives to the objectives of the project team.
- 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.
- Represents the organization in providing solutions to difficult technical problems; frequent inter-organizational and global contacts.
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.
