Validation Engineer/Scientist

Eli Lilly and Company • Pleasant Prairie, WI

1d • $66,000 - $171,600 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
• 2+ years’ experience supporting cGMP manufacturing preferred (within validation, engineering, technical services, operations, quality assurance, etc.)
• Experience supporting cGMP manufacturing (specifically within operations, validation, engineering, technical services, quality assurance, etc.)

Nice To Haves

• Experience executing equipment qualification, cleaning validation, and sterilization validation
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems
• Possess strong interpersonal skills to work cross-functionally within a team.
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills

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 and support the execution of validation protocols and reports.
• Provide technical guidance to the Process Team for cleaning and sterilization processes.
• Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities.
• Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes.
• Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.
• Implement process changes and improvements through the technical agenda.
• (Senior/Principal) Serve as cleaning and/or sterilization interface external to the Lilly Kenosha County site.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level