All Of Our Groups
Healthcare
ValidationEngineer/Scientist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Validation Engineer/Scientist at All Of Our Groups. Skills: Validation, Sterilization, Cleaning, Manufacturing. Develop validation of production equipment. Support validation of production systems”
What You'll Achieve.
Successful start-up; Improve process control; Improve yield; Improve product quality; Improve productivity
Industry & Context.
Root cause investigations; Data analysis
Available off shift, 10% travel
What They're Looking For.
Must Have
Bachelor's degree in microbiology, Bachelor's degree in Biology, Bachelor's degree in Biochemistry, Bachelor's degree in Biochemical Engineering, Bachelor's degree in Chemical Engineering, 2+ years' experience supporting cGMP manufacturing, Experience supporting cGMP manufacturing
Nice to Have
Experience executing equipment qualification, Experience executing cleaning validation, Experience executing sterilization validation, Experience with data trending and analysis, Ability to analyze complex data, Possess interpersonal skills to work cross-functionally, Self-management skills, Organizational skills
What You'll Do.
Develop validation of production equipment
Support validation of production systems
Provide technical leadership
Develop validation strategies
Implement validation strategies
Support start-up activities
Support compliant manufacturing
Develop cleaning strategies
Develop sterilization strategies
Develop filter validation strategies
Support periodic requalification activities
Author validation protocols
Support execution of validation protocols
Author validation reports
Support execution of validation reports
Provide technical guidance
Lead root cause investigations
Provide technical support for investigations
Analyze manufacturing data
Identify process disruptions
Identify opportunities for improvement
Coordinate with process teams
Improve cleaning processes
Improve sterilization processes
Provide guidance for equipment cleaning programs
Provide guidance for equipment sterilization programs
Prepare technical documents
Review technical documents
Approve technical documents
Support preparation of technical documents
Support TS/MS technical projects
Improve process control
Improve product quality
Implement process changes
Implement process improvements
Serve as cleaning interface
Serve as sterilization interface
Lead cross-functional teams
Implement TS/MS objectives
Deliver on business plan
Deliver on quality objectives
Collaborate with partners
Ensure safe working environment
Comply with safety rules
Improve safety culture
Participate in safety activities
How You'll Work.
Team & Collaboration
Cross-functional process teams; Cross-functional teams; Parenteral Network partners; Product supply chain teams
Full Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. **Position Overview:** The Validation Engineer/Scientist – Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of Lilly Kenosha County products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to validation activities. **Responsibilities:** * Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Develop or assist in the development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators) * Support periodic requalification activities for production equipment and systems. * Author a
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