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

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A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

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, serving as the authority on inspection standards, defect classification, and process capability.

Primary 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

Perform Annual Defect Trending by product type per USP .

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

Minimum Qualifications

Strong working knowledge of GMPs, USP / , Annex 1, and applicable FDA / EMA

regulations

Preferred Qualifications

a LEAN manufacturing environment

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

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100,000.00 - $148,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Management and Manufacturing

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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