Operations Engineer

As Value Stream Engineer, you will be providing 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.

Responsibilities:

• Manage deviation investigations and CAPAs of high complexity and related to process or technical events.
• Support Manufacturing Operations in tracking process parameters.
• Support Quality and business-quantity risks.
• Gap Analysis of QMS, Quality alerts and GQMPs/GGs.
• Prepare documents and trainings materials as required to support the activities of the department.
• Identify, manage, and execute improvement initiatives in batch record improvement, process improvement, alar...