Jobs at Akouos

This role will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems across the site. This role will collaborate with cross-functional teams, providing expertise in validating systems critical to the manufacture of life-changing products at the new site.

• 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 etc) and corporate Lilly quality policies and procedures
• Generate and maintain validation documentation, such as validation plans and summary reports
• Develop local site procedures (e.g SOPs, Work Instructions etc) related to automation systems
• Manage change control and deviation management as it pertains to CSV activities
• Collaborate with vendors to ensure that 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 (e.g CSA) 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 document relating to automation systems

Operational Excellence:

• Review and oversee the 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 (such as plant historians) used to capture process automation related production data
• Maintain the validated state of the site control systems in line with Lilly quality standards including the development and execution of validation strategies and associated 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 leveraging corporate expertise when needed

Organizational Capability:

• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.

Organizational Capability:

• Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
• Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement
• Demonstrated ability to influence peers and business partners
• Good written and verbal communication skills for both technical and non-technical audiences
• Knowledge of GMP, regulatory requirements, computer system validation

Basic Requirements:

• Minimum B.S. in Engineering or similar degree (Ph.D's will not be considered at this level).
• 2+ years working experience in FDA regulated environments
• Experience with design, development, commissioning, or qualification of computer systems
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Deep knowledge of GMP/GXP, regulatory requirements, computer system validation and data integrity
• Experience in Automation Engineering, preferably in major pharmaceutical manufacturing
• 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.

Other Information:

• Initial location in Carmel, IN
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.