Process Engineer

Description

• Manage changes to equipment/process as per site change control procedures.
• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
• Provide technical leadership within a new Vaccine Drug Product Manufacturing facility.
• Ensure all company and site engineering policies and procedures are adhered to.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.
• Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite.
• Generate and execute documentation for cGMP activities including risk assessments /reports.
• Management of Equipment Vendors including execution of on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.

Requirements

• Experience in executing on the floor activities such as FAT, SAT, IQ/OQ
• Experience in leading & resolving complex technical investigations.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma
• Ability to adapt to changing priorities as project demands change.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA
• Minimum 5 years cGMP industrial / engineering experience,

Benefits

For further information, feel free to message.

Training + Development

Interview process

Visa Sponsorship

Security clearance