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Process Engineer (Upstream/Downstream)
| Institution |
Baxter BioScience, Singapore |
| City |
Woodlands |
| Country |
Singapore |
| Job Title |
Process Engineer (Upstream/Downstream) |
| Description |
Baxter Bioscience Singapore is a biotechnology plant. The long term mission of this Manufacturing plant is to produce multiple products.
Within the Singapore organization, the primary mission for the Technical Services team is to support manufacturing operations to meet the plant goals in terms of quality, yield, capacity and timelines. Another specific objective of the TS team is to support process transfer between Baxter Bioscience plants and from R&D.
In the Technical Services organization, the job holder reports to the Technical Service Group Leader. He works in close collaboration with
- Other Process Engineers or technical experts (within or outside the Singapore plant)
- Production, Quality Assurance and Engineering departments
This position is responsible to support :
- The manufacturing operations
• to resolve process issues
• to improve and/or optimize processes
- The manufacturing, engineering and validation groups
• to transfer new technologies
• to manage process validation programs
• to support the training of the manufacturing and technical staff
The job holder is a process expert which technical and scientific skills covers the following process steps (down scale and commercial scale) :
FOR CELL CULTURE
- Cell amplification in flasks as well as in stirred tank (batch mode)
- Continuous culture operations
- Harvest clarification (i.e. cell removal)
- Cell culture media preparation and storage
FOR PURIFICATION
- Affinity chromatography
- Anion and cation exchange chromatography
- S/D treatment
Main accountabilities
- START-UP OF RECOMBINANT PROCESSES
• support the qualification of new equipment (IQ, OQ)
• develop, write and execute process/engineering parameter setup (cycle development), performance qualification (PQ) and process validation (PV)
• resolve process and quality issues at start-up
• develop training programs and train manufacturing leaders/trainers
• develop, write and maintain SOPs of critical process operations
- CURRENT VALIDATED PROCESSES
• analyze process trends and monitor process performances to guarantee achievements of manufacturing goals (quality, capacity)
• support Manufacturing and Quality to resolve process and quality issues / Lead critical investigations to identify root cause / Implement action plans to correct or prevent re-occurrence
• improve/optimize existing processes and procedures / Plan and execute a global Yield Improvement Program (YIP)
- NEW PROCESSES
• evaluate, propose new manufacturing technologies and/or equipment to improve manufacturing performances (quality, capacity)
• participate to budget preparation required to implement new processes
• develop and write related procedures and protocols
• participate actively in new technology transfer
• support Manufacturing group in the startup of new processes (incl. Training)
- GENERAL
• accomplish technical tasks in close collaboration with Mfg, QA and Engineering staff.
• Focused on the customer satisfaction : quality, timeline, costs
• comply with c-GMP, EHS and other Baxter requirements |
| Category |
Manufacturing |
| Keywords |
Process |
| Education |
- Master or Bachelor Degree in Cell Biology and Bioengineering (Specific Cell Culture)
- Master or Bachelor Degree in Protein Biochemistry (Specific Purification) |
| Experience |
>2 years experience in Biotech industry |
| Work experience |
- Good knowledge of c-GMPs
- Ability to write technical and scientific reports |
| Primary Language |
English |
| Secondary Language |
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| Other Requirements |
- Team worker
- Good communication skills, esp. in different cultural environment
- Leadership and proactivity
- Focused on customer satisfaction |
| Reference |
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| Comments |
For more details and application of position, please visit and deposite your resume at www.baxtercareers.com.sg
Only shortlisted candidates will be notified. |
| Job created |
Jan 15, 2010 09:46:49 |
| Job last modified |
Feb 25, 2010 08:02:16 |
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