Operations Engineer 1

2 weeks ago

Complex, Singapore GSK Full time
工作地點名稱: Singapore - Tuas
刊登日期: Apr

To provide process and technical support to the Manufacturing Operations teams to enable Value Stream to deliver its operational objectives. Areas of support includes process optimization, validation activities, continous improvement, change management, deviation investigation and production project management to ensure that Value Stream can operate optimally and in compliance with cGMP requirements.

Responsibilities


1. Operations

a) To support Manufacturing Operations in the following areas:

  • Manage deviation investigations and CAPAs of high complexity and related to process or technical events.
  • Changes including eCCs, SMRs and SAP master data (e.g. BOM)
  • Non-process specific training
  • Key participant in the Quality Review Board and be able to explain trends
  • Support Manufacturing Operations in tracking process parameters
  • Quality and business-continuity risks
  • Gap analysis against QMS (CQMPs, GGs) and Quality Alerts
  • prepare documents and training materials as required to support the activities of the operations department

b) Identify, manage and execute improvement initiatives in the following areas:

  • Batch records/SOPs
  • Process optimization
  • Alarms management
  • Materials management
  • Operational Excellence (OE) initiatives

c) Support Manufacturing Operations in executing validation, trials, development and technical transfer activities where necessary

2. Interface

  • Develop relationship within Value Stream team and with other departments (including MSAT, QA, QC TS etc) to ensure delivery of operational objectives

3. Management/ Leadership

  • Plan, manage and execute deliverable through proper and timely request and utilization of resources to ensure delivery of tasks and projects
  • Plan and coordinate effective utilization of ad-hoc team members (Manufacturing Operations Staff)

4. Technology Transfer

  • Participate in new technology and/or new process transfer
Knowledge, Skills & Experience
  • Degree in Chemical Engineering, Biotechnology, Life Sciences or other relevant field
  • Knowledge of cGMP and safety
  • Knowledge in Biotechnology equipment and process
  • Equipment and process troubleshooting skills
  • Knowledge in Lean Six Sigma tools
  • Knowledge in Project Management
  • Effective communication and team building skills
  • Effective organization skills
  • Effective project management skills

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