Operations Engineer 1

Singapore, Singapore

Job Description


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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Job Detail

  • Job Id
    JD1401967
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned