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Closing Date: 22nd January 2018
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Roche Singapore Technical Operations Pte Ltd
Senior Process Engineer I

Salary: 0.00

Key Responsibilities:
  • Support Manufacturing Operations in RSTO and is required to work effectively as part of a team responsible for ensuring successful and efficient processes for the production of clinical and marketed recombinant proteins.
  • Provide ongoing technical and scientific support for the unit operations utilized in the manufacture of these products.
  • Monitor, optimize, validate, and troubleshoot issues related to either fermentation/cell culture or protein purification processes
  • Design, procure, commissioning, and qualify new equipment
  • Support the technology transfer of new products/processes to RSTO or CMOs
  • Create, review, and revise and approve technical reports and engineering documents such as URS, FS, SDS, etc
  • Create, review, revise, and approve technical reports and cGMP documents such as production batch records, SOPs, etc.
  • Create, assess and approve change records
  • Develop training material and conduct training for production and technical staff
  • Perform product impact and root cause assessments for process discrepancies and Quality investigations
  • Identify and implement corrective actions and other process and equipment improvements
  • Develop, monitor, optimize, validate, and troubleshoot cleaning processes
  • Support regulatory inspections and filings as well as internal audits
  • Perform lab-scale experiments in support of process monitoring, improvements, and validation
  • Serve as Subject Matter Expert in support of risk assessments and hazards analyses
  • Serve as RSTO representative in global network teams such as PTTs, UOTs and task forces
  • Manage and develop Process Engineers (including assurance of compliance to EHS rules, GMP training and performance management)
  • Perform gap and impact assessments for global standards and procedures (GSPs and SOPs)
  • Provide assessment of site capabilities with respect to new or modified processes
  • Accountable for the Product and Process Monitoring program at the site as the Subject Matter Expert

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Requirements:
  • BA/BS or higher in a scientific or engineering discipline
  • Knowledge of safety principles, quality systems, and cGMP
  • Relevant work experience in a lab, pilot plant, or large-scale protein production processes and equipment
  • Experience with working in project teams
  • Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule
  • Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills

Appointment to this position will be on local Singapore salary and benefits package.





 
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