Process Engineer Ii - Singapore - ARIAD

ARIAD

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

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Description

Small Molecules

Biologics
Plasma
Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0117100
Date posted 02/09/2024
Location Singapore, Singapore

Job Title:
Process Engineer II (Upstream)

Location:
Woodlands, Singapore

About the role:

Support/lead troubleshooting of manufacturing operations (Upstream/ Downstream) process/product issues
Support evaluation of technologies, plan and execute process improvements
Support and execute global manufacturing science initiatives
Plan, support and execute site manufacturing science activities such as continuous process verification (CPV) program, technology transfer of new products and process monitoring and trending

How you will contribute:

Support site manufacturing (upstream) activities through

Planning and executing activities required for process investigation such as performing process impact assessment, participating and performing root cause analysis. Work with cross functional teams for process issues investigation
Analyzing process trends, monitoring process performance as part of the CPV program. Escalate and perform investigation in event of any out of trend or process issues
Leading process investigations to identify root cause and implement action plans to correct or prevent reoccurrence
Planning and executing process improvements and robustness projects
Leading/supporting cycle development for process parameters where applicable
Drafting process training slides and providing process training to cross functional teams
Raising change controls as change owners for process changes
Performing impact assessments for relevant change controls
Providing technical /process parameters for creation and revision of master batch records. Review master batch records.

Lead/Support technology transfer for new technologies/product introduction through

Leading/Supporting the evaluation of new manufacturing technologies and/or equipment for process improvement or process capabilities build
Planning and executing technical transfer activities according to project timelines. Raise change controls where applicable to support the technical transfer
Monitoring process performance and trending through the site CPV program. Proactively investigate where required to ensure process robustness.
Performing risk assessment, drafting required technical transfer and process control strategy documents and updating lifecycle documents
Authoring study and process validation protocols and reports where needed

Support audits, author regulatory submissions and responses

Support and execute global manufacturing sciences initiatives according to project timelines
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

Bachelor's Degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, Biochemical Engineering with minimum 4 years of relevant experience or Master's Degree with 2 years of relevant work experience or a fresh PhD in the relevant technical area.
Handson experience with cell culture/ upstream processes and/or downstream processes in a manufacturing or development environment.
Has knowledge of cGMPs

Key Skills and Competencies

Strong analytical skills including demonstration of systematic evaluation of potential issues, correlation or cause and effect relationships, root cause analysis methodology.
Good communication skill
Willingness to learn
Team worker/ able to work in matrix environment
Independent worker/ Self starter

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, o