Operations Engineer

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
• Minimum 5 years of working exper
• 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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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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