4355 ITOT PI Engineer
This position provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility.
The site employs highly integrated computer control systems to manage plant operations and manufacturing data.
The candidate will report to the local IT OT organization, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.
The IT OT Team is supporting Technical Operations (HTO) which is the commercial Aseptic filling for Drug Product and launch site for North America and Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.
Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks.
This include activities like:
Support OSI PI System Owner and Engineer in the overall procurement, development, integration, modification, operation, maintenance, and retirement of OSI PI.
Support validation activities.
Responsibility for the Periodic System Audit Trail Review.
Perform annual automation account review.
User account auditing, provisioning, resets and activation for all IT and OT systems.
Creating reports for various systems on demand.
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Disaster Recovery Documentation & Business Continuity Testing.
Manage the Internal and External Inspection Agency Support.
Perform IMS Tag creation and loading.
Review ServiceNow tickets and either address them or route them to the SME
Support on documents management systems (Veeva, Condor, eVal Roche)
Support the team with administrative tasks
Minimum Bachelor’s degree in Computer Engineering, Automation Engineering or similar.
Minimum 5 years of experience in system and/or network administration.
Attention to details and good problem-solving skills.
Demonstrated ability to think and solve problems at a system-level.
Ability to work and interact productively with stakeholders from different technical domains.
Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment.
Good team player, self-confident, motivated, and independent.
Good communication skills.
System administration, supporting multiple platforms and applications.
Biopharmaceutical or similar Manufacturing domain knowledge.
Application Engineering experience with manufacturing management systems, such as Data Historian (e.g. OSI PI ).
Solid understanding of the Aveeva / OSIsoft PI System.
Experience designing, planning, and deploying secure, optimized, reliable, and highly available PI System architectures.
Experience installing, configuring, validating, and tuning PI Server components and PI Interfaces.
Experience implementing PI analytics with PI Asset Framework and Performance Equations.
Experience installing and configuring OSIsoft PI system for specific use cases including condition based maintenance, process optimization, process visualization, alarming and notification, and reporting.
Experience working with PLC and DCS-based control systems and building management systems as data sources for the PI System.
Advanced analytical and troubleshooting skills with methodical approaches to solving difficult problems.
Solid understanding of Windows Server OS, networking, and security fundamentals.
Experience installing and configuring KepServerEX.
Experience installing and configuring OPC DA and OPC UA servers to support PI Interfaces.
Keep abreast of key Manufacturing IT trends and be curious – Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
Compensation Range: $65hr -$70.80hr