Process Engineer I

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Job Description

About the role:

Process Engineer I 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. Coordinates improvements and change controls associated with designated systems. Provides tactical support for ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business. Proficiency with troubleshooting equipment and performing formal root cause analysis investigations

How you will contribute

• Act as system technical owner for upstream, downstream equipment and other unit operations.

• Raise and Lead the Quality Event (Deviation) process and ensure timely creation, analysis and closure of events

• Raise and lead Change Control for implementation of changes to equipment / facilities

• Troubleshoot and fault find equipment’s which are not operating to expected parameters when identified and post preliminary troubleshooting by Maintenance.

• Provide on the floor troubleshooting support for manufacturing operations especially with regard to equipment issues

• Escalate issues to department Lead/Manager as appropriate following initial troubleshooting if issues cannot be resolved

• Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations.

• Timely closure of EHS and Quality event investigation and Corrective Actions / Preventative Actions (CAPA) tasks

• Participate as Process Engineering representative on cross functional support team meetings.

• Primary liaison for engineering for RCAs and investigations

• Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements

• Assist Validation Department 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 with others and behaviour in accordance with Takeda’s Code of Conduct.

• Any other duties as assigned by the supervisor.

What you bring to Takeda:

Education and Experience Requirements

• Degree in Chemical/Bio/Process/Mechanical engineering or equivalent Engineering Discipline with 1-3 years of experience is required.

• Diploma in Chemical/Bio/Process/Mechanical engineering or equivalent Engineering Discipline with >3 years of experience is required.

• Experience in bio-processing engineering in a manufacturing environment is highly desirable

• 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

• 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

• Good communication skills

• Knowledge/ Experience in DCS, PLC, OSIPI and Electronic Batch Management systems is an added advantage

• Thorough knowledge of current Good Manufacturing Practices (cGMP) and QbD

• Good knowledge of EHS and risk management practices.

• Good Project Management Skill

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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