Operations / Senior Operations Engineer

5 days ago

Singapore No Deviation Pte Ltd Full time

**Purpose**

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, continuous improvement, change management, deviation investigation and production project management to ensure that Value Stream can operate optimally and in compliance with cGMP requirements.

**Key Responsibilities Area**

**Operations**

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

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

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

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

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

**Management**
- Plan, manage and execute deliverables 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)

**Leadership (Senior Engineer)**
- Coach and provide guidance to the Operations Engineer in their execution of daily tasks
- To assist the Senior Operations Executive/Manufacturing Manager in ensuring the quality and delivery of tasks and projects

**Technology Transfer**

Participate in new technology and/or new process transfer

This is a contact role, but it is convertible to a permanent role depending on your performance.

**Skills, Knowledge, and Experience**

**Professional**:

- Degree in Chemical Engineering, Biotechnology, Life Sciences or other relevant field
- Minimally 5 years’ experience in Medical Devices or Pharmaceutical Industry

**Technical**:

- Knowledge of cGMP and safety (biosafety)
- Knowledge in Fermentation and Purification is preferred but not mandatory
- Knowledge in Biotechnology equipment and process
- Equipment and process troubleshooting skills
- Knowledge in Lean Six Sigma tools
- Knowledge in Project Management

**Business**
- Effective communication and team building skills
- Effective organization skills
- Effective project management skills
- Ability to work independently
- Problem solving and analytical skills

EA Reg. No : R2094147 EA License No : 19C9587

**Job Type**: Contract

**Salary**: $3,500.00 - $5,000.00 per year

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