Senior/Sr. Principal Automation Engineer, Quality Assurance

Position Description

The Senior/Sr. Principal Automation Engineer - Quality Assurance serves as the site subject matter expert for Computer System Validation (CSV), automation compliance, and data integrity for GMP computerized systems including DCS, SCADA, MES, Historians, Building Management Systems and supporting automation platforms.

This role provides strategic leadership for the validation, maintenance, and lifecycle management of GMP computerized and automation systems supporting Oral Solid Dose (OSD) manufacturing operations at the Katwijk site.

In addition, this role is also responsible for the definition, implementation, and maintenance of data integrity controls in GMP regulated computer systems. This includes working with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and external Regulatory agency inspections; conducting evaluations of internal or supplier quality practices; maintenance of inspectional readiness; and external benchmarking of computer system validation practices. Finally, this position will leverage an understanding of GMP data flows (electronic and paper), the application of data management/integrity principles in the site's processes, and validation/maintenance requirements to support regulatory compliance, consistency, and sustainment.

Responsibilities

Deliver on CSV Processes and Data Integrity Sustainability

• Establish and maintain CSQ support and DI sustainability processes.
• Drive appropriate consistency in CSQ and DI controls.

Deliver Projects and Programs

• Serve as the site subject matter expert for automation system validation including DCS, SCADA, MES, Historian, Building Management Systems and other GMP computerized systems.
• Provide strategic leadership for CSV activities associated with automation systems throughout design, implementation, qualification, operation and retirement.
• Lead the development and implementation of site CSV strategies and governance models to ensure the ongoing validated state of GMP computerized systems throughout their lifecycle.
• Partner with Automation, Engineering, Quality and Tech@Lilly teams to ensure GMP compliance, data integrity and maintenance of validated automation systems.
• Support commissioning, qualification and validation activities for automated manufacturing systems and equipment.

Grow Capabilities and Knowledge

• Mentor others in DI and CSV-related roles.
• Grow capabilities of those performing DI CSV activities.

Maintain Inspection Readiness

• Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the Katwijk site.
• Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems or data integrity.
• Monitor current state of inspection-readiness.
• Escalate issues appropriately.

Streamline and Continuously Improve

• Promote common process and best practice across functions.
• Identify systemic issues and trends across functions and drive improvement activity.
• Understand the external environment/best practices and bring external learning back to Lilly.

Basic Requirements

• Bachelor's degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field.
• Minimum of 10+ years of experience in pharmaceutical automation, computer system validation (CSV), quality assurance, engineering, or related GMP-regulated manufacturing environments.
• Experience supporting API and/or Oral Solid Dose (OSD) manufacturing operations.
• Experience with automation platforms, manufacturing control systems and computerized system lifecycle management.
• Candidates must have current authorisation to work in the European Union.

Additional Preferences

• Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).
• Previous experience in GMP or GLP environments.
• Demonstrated strong oral and written communication skills.
• Strong interpersonal interaction skills.
• Proven ability to influence quality peers, IT SMEs, and upper management.
• Previous experience in Business Quality Assurance and Automation.
• Understanding of process development and/or improvement (e.g. Six Sigma).
• Knowledge of Lilly business area and its impact to products and patients.
• Experience with automation systems including DCS, SCADA, MES, Historians, PLCs and Building Management Systems.
• Experience supporting commissioning, qualification and validation of automation systems in greenfield pharmaceutical manufacturing facilities.
• Demonstrated expertise in GAMP5, Data Integrity, ALCOA+, and computerized system lifecycle management.
• Experience leading cross-functional CSV and automation compliance initiatives.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

€60,000 - €99,000

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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