Equipment Technology- Process Engineer
1. General Information:
Job Title: Process Engineer
Department: Equipment Technology, Core Engineering
Position Reports to: Equipment Technology People Manager
Your role will be to support the Equipment Technology Team at Grange Castle to work on capital and sustaining projects across the Drug Substance, Vaccines, BioProcessing and Parenterals Operating Units on site as applicable.
The job holder will provide technical expertise to ensure that systems, equipment, and processes are designed, installed, commissioned, and qualified to Pfizer’s and regulatory specifications.
Within this role you will:
• Deliver technical support for equipment specification and procurement during design phase of projects.
• Generate, review and approve documentation for cGMP commissioning/ verification/qualification of systems, equipment, utilities and manufacturing processes.
• Raise and Implement equipment change controls and ECM’s.
• Participate in Delta V FDS reviews for new/ modified process equipment phases and utility phases.
• Perform testing on the Delta V Development System.
• Participate in construction system completion walkdowns.
• Perform shakedown and commissioning of new equipment and modifications to existing equipment.
• Perform temperature mapping/Autoclave Qualifications.
• Perform execution of Verification Test Protocols in field.
• Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
• Develop and implement changes required to resolve deviations/ events effectively.
To be successful in this role you will require:
• B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical of process engineering.
• Minimum of 4 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
• Demonstrated ability to work on own initiative and proactively respond to business needs.
• Experience with operation and commissioning of system automated with DeltaV/MCS is a plus
• Excellent interpersonal and communication skills.