Process System Engineer (Plant Engineering)

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Job Description

Job Title: Process Systems Engineer (Plant Engineering)

Location: Woodlands, Singapore

About the role:

• 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

• Trouble shoots and resolves technical equipment problems and takes corrective action.

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

• 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

• Assist Validation Department with execution of qualification protocols including IQ, OQ, and PQ

• Own and implement CAPEX Project for Process Engineering and ensure timely implementation and closure

• Primary liaison for engineering for RCAs and investigations

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

• process and equipment knowledge of biological drug substance manufacturing processes; upstream /downstream unit operations expertise highly preferable.

• Experience in an engineering role supporting cGMP operations in a pharmaceutical/ biopharmaceutical manufacturing plant is required

• Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts

• 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

• A good understanding of design principles and standards within the biopharmaceutical facilities

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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