Visual Inspection Subject Matter Expert- Parenteral Products

Eli Lilly • Indianapolis, IN

387d

About The Position

The Visual Inspection Subject Matter Expert (SME) for Parenteral Products at Lilly is responsible for overseeing and enhancing the visual inspection program to ensure the highest quality standards for injectable pharmaceutical products. This role involves providing expert guidance on inspection methodologies, leading training programs, optimizing systems, and ensuring compliance with regulatory requirements. The SME will leverage in-depth technical knowledge and strong analytical skills to drive product quality and patient safety.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related field; advanced degree preferred.
• 5+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment.
• In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products.
• Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections.
• Proven track record of developing training programs and mentoring inspection teams.
• Strong analytical and problem-solving skills, with attention to detail and a commitment to quality.
• Experience with automated inspection systems and/or artificial intelligence for quality control is a plus.

Nice To Haves

• Experience with automated inspection systems and/or artificial intelligence for quality control.

Responsibilities

• Lead the design, development, and implementation of visual inspection standards for parenteral products.
• Evaluate and validate visual inspection processes, including both manual and automated inspection methods.
• Establish risk-based inspection strategies for different types of parenteral products and materials.
• Harmonize visual inspection control strategies across the internal and external manufacturing network.
• Serve as the go-to expert on visual inspection processes, equipment, and quality standards.
• Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality-related events.
• Collaborate with cross-functional teams to identify and implement process improvements.
• Develop and deliver training programs for quality inspectors and operators.
• Mentor junior staff and develop training materials to promote inspection skills.
• Ensure compliance with FDA and global regulatory standards by keeping inspection processes and documentation up-to-date.
• Participate in internal and external audits, providing expert insights and support.
• Act as subject matter expert for the development and maintenance of internal quality system documents.
• Explore and evaluate new technologies and methodologies in visual inspection.
• Identify opportunities for process automation and work closely with engineering teams.

Benefits

• Eligibility to participate in a 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;
• Wellbeing 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
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree