Visual Inspection Subject Matter Expert- Parenteral Products

BioSpace; Indianapolis (IN); On-site; USD 144,000 - 211,200; Full time

Benefits offered by this job

401(k) and pension benefits

Flexible benefits

Employee assistance program

Job summary

A leading pharmaceutical company in Indianapolis is seeking a Visual Inspection Subject Matter Expert to oversee the visual inspection program for parenteral products. The ideal candidate will have extensive knowledge in visual inspection standards, regulatory compliance, and training development. This role requires on-site presence and offers competitive compensation ranging from $144,000 to $211,200 annually, along with comprehensive benefits.

Qualifications

• 10+ years of experience with parenterals in a GMP-regulated environment.
• At least 5+ years of experience in visual inspection for injectable pharmaceutical products.
• In-depth knowledge of visual inspection practices specific to parenteral products.

Responsibilities

• Lead the design and implementation of visual inspection standards.
• Conduct root cause analyses and implement CAPAs.
• Develop training programs focusing on visual inspection adherence to GMP.

Skills

Visual inspection standards

Analytical skills

Quality assurance

GMP compliance

Education

Bachelor’s degree in Pharmacy, Chemistry, Engineering or related field

Tools

Automated inspection systems

Job description

Visual Inspection Subject Matter Expert – Parenteral Products

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Pay

Pay found in job post

Base pay range

$144,000.00/yr – $211,200.00/yr

Job Summary

We are seeking a highly skilled and detail‑oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and enhancing our visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance on inspection methodologies, lead training programs, optimize systems, lead harmonization of visual inspection control strategies across the internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical knowledge, strong analytical skills, and a commitment to product quality and patient safety.

Key Responsibilities

• Visual Inspection Program Development:
  • Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices.
  • Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes.
  • Establish risk‑based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes).
  • Harmonize visual inspection control strategies and practices across the internal and external manufacturing network.
• Technical Expertise & Process Optimization:
  • Serve as the go‑to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines.
  • Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events.
  • Collaborate with cross‑functional teams (QA, manufacturing, engineering, TSMS) to identify and implement process improvements that enhance efficiency and reduce inspection errors.
• Training & Development:
  • Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements.
  • Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization.
• Compliance & Documentation:
  • Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up‑to‑date and audit‑ready.
  • Participate in internal and external audits, providing expert insights and support for any inspection‑related findings.
  • Act as subject matter expert for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices…) and execution documents (validation reports, PoDs…) to support the visual inspection Quality System.
• Innovation & Continuous Improvement:
  • Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
  • Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies.

Basic Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related field (relevant advanced degree preferred).
• 10+ years of experience with parenterals in a GMP‑regulated environment, with at least 5+ years of experience in visual inspection for injectable pharmaceutical products.
• 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.

Additional Preferences

• 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.
• Formal or technical leadership experience.

Additional Information

• This role will require travel (40‑50%) both domestic and international.
• This is NOT a remote position and will require on‑site presence.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 – $211,200.

Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well‑being benefits framework (e.g., employee assistance program, fitness benefits and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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