Eli Lilly and Company · 1 week ago
Senior Principal Engineer - Automation Engineering – CSV
Lebanon, IN
Full-time
Onsite
Senior Level, Lead/Staff
$66K/yr - $172K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving life for people around the world. The Senior Principal Engineer - Automation Engineering will provide automation support and lead computer system validation activities for process automation systems, ensuring compliance and reliability in manufacturing processes. This role includes mentoring employees and collaborating with cross-functional teams to optimize manufacturing operations at the new Lilly Medicines Foundry.
BiotechnologyHealth CareMedicalPharmaceutical
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 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
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
In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products
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
Qualification
Required
Minimum B.S. in Engineering
Experience in Automation Engineering, preferably in major Pharmaceutical manufacturing handling System integration of applications, systems and platforms
Minimum of 2 years working experience in Biopharma engineering, operations, or manufacturing
Knowledge of GMP, regulatory requirements, computer system validation
Preferred
For internal Lilly employees - LRL/Product Research Development experience preferred
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
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
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Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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