Automation Engineer

Key Responsibilities:

• Automation Testing Protocols:
• Author, review, and execute automation testing protocols such as SFAT, Installation and Operational Qualification, and Verification testing in alignment with specifications throughout the system lifecycle phases from concept to decommissioning.
• Automation Protocol Approval:
• Develop and obtain approval for automation testing protocols that meet specifications, including User Requirements Specification (URS), Design Definition Specification (DDS), Functional Specification (FS), and Configuration Specification (CS).
• Testing Execution:
• Execute and complete automation testing on-site and/or in a simulated environment, ensuring all systems meet required specifications.
• Virtual Machine and Application Validation:
• Support the deployment and validation of virtual machines and applications, ensuring they meet performance, reliability, and compliance standards.
• System Integration Validation:
• Validate the integration of packaged systems utilizing communication protocols such as TCP/IP and support/validate integration of site systems with corporate systems using protocols such as OPCDA and RDBMS.
• Automation Protocol Review and Approval:
• Support automation protocol pre-execution and post-execution review, obtaining necessary approvals as required for testing.
• Vendor Site Oversight:
• Oversee execution of automation testing protocols at vendor sites, ensuring proper change management processes are followed.
• Good Documentation Practices (GDP):
• Execute and apply Good Documentation Practices (GDP) in test documentation for commissioning, qualification, assessments, and other related activities, driving the completion of all required documentation.
• Qualification and Assessment:
• Perform Design Qualification (DQ) and Required Assessment of automation systems in compliance with GxP, GAMP, and regulations related to Electronic Records and Electronic Signatures.
• Cross-Functional Support:
• Provide strong cross-functional support across various groups, including engineering and quality assurance teams, to ensure successful integration and validation of automation systems.

Required Knowledge, Experience, and Skills:

• cGMP Knowledge:
• Comprehensive understanding of current cGMP (current Good Manufacturing Practices) requirements for pharmaceutical manufacturing.
• Automation System Experience:
• Working experience with automation systems, including Rockwell PlantPAx, GE UniCorn, Intellution iFIX, Allen-Bradley HMI/PanelView, and Delta Controls Building Automation System is highly preferred.
• Industry Guidance Expertise:
• Strong working knowledge of relevant industry guidance documents, including E2500, CFRs, EudraLex Annex 11, S88, and GAMP ISPE guidance related to automation systems and validation processes.
• Hands-on Automation Engineering:
• Hands-on experience in automation engineering, including configuration setup, coding, and troubleshooting of automation systems is a plus.
• Documentation Expertise:
• Proficient in preparing and executing validation documentation following Good Documentation Practices (GDP).

Preferred Qualifications:

• Experience with GxP, GAMP, and electronic records regulations (21 CFR Part 11, Annex 11).
• Familiarity with electronic validation tools and automated testing software.
• Strong communication and organizational skills to support collaboration across departments and teams.
• Ability to work independently and manage multiple priorities in a fast-paced environment.