Senior Principal Engineer - Automation Engineering – CSV

Role Summary

Senior Principal Engineer - Automation Engineering – CSV. Provide automation support across operating areas and capital projects, lead and execute CSV activities for process automation systems, and mentor team members to ensure reliable and compliant control applications and systems in manufacturing.

Responsibilities

• Technical Leadership
• Mentor process control team, including design, controls philosophy, implementation and commissioning
• Process control validation testing, implementation and coordination
• Develop and implement the Automation Engineering Project Validation Plan
• Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: Process Automation Systems (DCS, SCADA, BMS, MES, Historian); Building Management System; Vendor Packaged Equipment; Data Historian; Automated Storage and Retrieval System; QMS
• Perform risk assessments for computerized systems and develop strategies to mitigate identified risks
• Develop and Execute validation protocols for computerized systems
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and corporate Lilly quality policies and procedures
• Generate and maintain validation documentation, such as validation plans and summary reports
• Develop local site procedures related to automation systems
• Manage change control and deviation management as it pertains to CSV activities
• Collaborate with vendors to ensure third party systems and software meet validation requirements; conduct vendor audits as needed
• Provide training to personnel on CSV principles, procedures and best practices
• Stay informed of industry trends and advancements in CSV and automation technologies
• Represent the automation department during audits by regulatory agencies as assigned
• Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents relating to automation systems

Operational Excellence

• Review and oversee design documentation including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications and execution
• Lead/participate in design reviews and Automation application software reviews to ensure compliance and standardization
• Provide periodic status updates to Project Management
• Devise CSV and quality strategies for control systems in collaboration with Site Quality organization
• Implement and support electronic systems used to capture process automation related production data
• Maintain the validated state of the site control systems in line with Lilly quality standards including validation strategies and documentation
• Automation support for capital projects including new product introductions
• Promote the use of automation to improve productivity, operational efficiency and compliance
• Develop a network of corporate contacts and leverage corporate expertise when needed

Organizational Capability

• Set and reinforce standards for appropriate rigor in automation work products
• Demonstrated initiative, planning and organizational skills with ability to prioritize tasks and meet deadlines
• Strong problem-solving skills and desire for continuous improvement
• Ability to influence peers and business partners
• Good written and verbal communication skills for technical and non-technical audiences
• Knowledge of GMP, regulatory requirements, computer system validation

Qualifications

• Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major Pharmaceutical manufacturing with system integration of applications, systems and platforms
• 8+ years working experience in Biopharma engineering, operations, or manufacturing
• Knowledge of GMP, regulatory requirements, computer system validation
• Deep knowledge of GMP, regulatory requirements, computer system validation and data integrity
• Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI)
• Experience in commissioning, qualifying and supporting systems between SCADA, DCS, MES, LIMS, Historian and other applications for interconnectivity
• Experience in design, development, commissioning and qualification activities ensuring quality compliance and data integrity
• Experience in facilitating and driving decision-making at an organizational level

Additional Requirements

• Accommodation requests may be required to submit a resume; applicable process for accommodations