Bachelor's or Master's degree in Computer Science or Engineering.
Project Management Professional (PMP) certification preferred, with knowledge of Agile methodologies.
Minimum of 3 to 5 years of experience in a GMP (Good Manufacturing Practice) environment, supporting computer system infrastructure and applications builds and operations.
Responsibilities:
Ensure the qualified state of the system, including technical change management, deviation/exception management, risk management, mechanical/electrical/structural integrity, data integrity, operational reliability, and lifecycle management.
Approve system lifecycle qualification/validation documents and risk documentation, as well as standard operating procedures.
Execute periodic qualification reviews of the system.
Manage user access approval and removal, including conducting annual user access reviews.
Provide appropriate training to personnel managing the computerized system.
Offer 24/7 on-call support for system issues.
Ensure all required SOPs (Standard Operating Procedures) are in place.
Oversee the establishment and supervision of vendor support agreements, including vendor personnel providing support.
Accountable for all system maintenance activities that may be delegated to others.
Conduct periodic audit trail reviews.
Act as the primary point of contact and architect for new system builds and enhancements at the Vacaville site.
