All Of Our Groups

Healthcare

ValidationEngineer/Scientist

$66–172k Pleasant Prairie, Wisconsin, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Root cause investigations; Data analysis

Eligibility Requirements

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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