Manager, Visual Inspection SME Job at BioSpace in Olde West Chester

Overview

The Visual Inspection Subject Matter Expert (SME) is responsible for technical oversight, regulatory compliance, and continuous improvement of manual, semi-automated, and fully automated visual inspection processes for sterile injectable drug products. The SME ensures inspection methods, acceptance criteria, and qualification practices are fully compliant with global regulatory requirements (USP Visible Particulates in Injections, USP Visual Inspection of Injections, EU GMP Annex 1, PDA TR-79) and applicable FDA / EMA expectations. This position serves as the primary point of contact for internal and external audits, acting as the authority on inspection standards, defect classification, and process capability.

Resilience is a technology-focused biomanufacturing company building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptions, support scientific discovery, and reach those in need.

For more information, please visit www.resilience.com .

Responsibilities

Regulatory Compliance and Inspection Readiness

• Act as the site technical authority for visual inspection requirements during FDA, EMA, MHRA, and other health regulatory inspections and client inspections.
• Maintain and ensure SOPs, work instructions, and training materials reflect current regulatory guidance and industry best practices.
• Respond to audit observations, prepare evidence packages, and provide SME testimony during inspections.
• Ensure all cGMP requirements are met during inspection operations, training, and qualification activities.
• Ensure defect classification and acceptance criteria are documented and approved per regulatory expectations.
• Always keep inspection processes and documentation audit-ready.

Defect Management and Training Programs

Training and Qualification Leadership

Operational Oversight

Process Improvement and Technical Support

Deviation, CAPA, and Change Control Management

Leadership and Cross-Functional Collaboration

Data Analysis and Continuous Improvement

Qualifications

Minimum Qualifications

Preferred Qualifications

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or perception, national origin, age, marital status, protected veteran status, disability status, or other non-job-related characteristics or grounds in applicable laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers a robust total rewards program including an annual bonus, 401(k) with company match, comprehensive benefits, paid time off, and tuition reimbursement. Target base pay range for this position is $100,000.00 - $148,750.00 per year. Actual pay depends on location, experience, qualifications, and other factors. We invite you to apply and speak with a recruiter.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Management and Manufacturing

Industries

Biotech / Life Sciences

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