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 <790> Visible Particulates in Injections, USP <1790> 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
Minimum Qualifications
Preferred Qualifications
- 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.
- Own the defect lab, including the coordination of support staff, control of the defect library, and photographic documentation of defects.
- Oversee Defect Classification Risk Assessment, conducting annual re-evaluations and updates.
- Maintain particulate/fiber evaluation process for site, providing daily results to Filling Technical Team and QA.
- Perform Annual Defect Trending by product type per USP <1790>.
- Collect, monitor, and analyze defect kit and training program data to identify improvements and update kits as needed.
- Accountable for training inspection personnel on processes on the manual inspection process.
- Partner with PET staff to develop training plans and escalate concerns when identified.
- Provide resources for training and manage the qualification/re-qualification program for manual inspectors, inline inspectors, AQL personnel, and Pack personnel.
- Schedule all required annual re-qualifications and visual acuity testing.
- Ensure all training documentation meets company standards and is compliant with cGMP.
- Ensure safe work practices are followed and all EHS standards are met.
- Monitor environmental factors such as illumination levels, background contrast, and inspection time limits for compliance.
- Maintain presence across multiple shifts to ensure consistent application of inspection standards.
- Lead the design, development, and implementation of visual inspection standards for parenteral products.
- Validate manual inspection processes to ensure optimal defect detection while controlling false rejects.
- Establish risk-based inspection strategies for different container types (vials, syringes, cartridges).
- Stay current with evolving industry standards and proactively update processes to maintain compliance.
- Promote continuous improvement in efficiency, quality, production, and safety, using team-driven processes and recognition of high performance.
- Generate deviation reports, leads or assist in investigations, recommend solutions, and approve investigations with appropriate.
- Implement corrective and preventive actions (CAPAs) for quality events, ensuring follow-up effectiveness checks are completed.
- Review, approve, and implement change controls impacting operations.
- Provide SME-level risk assessments for changes and processes, defect criteria, or inspection technology.
- Provide career development and performance management for direct reports.
- Promote a positive work environment through effective communication, policy administration, and employee engagement.
- Work collaboratively across PETs to ensure product flow, share best practices, and support lean behaviors.
- Act as delegate for Sr. Manager when designated.
- Analyze reject and reinspection data to identify false reject rates, detection capability, and trending of defect categories.
- Initiate and lead continuous improvement projects to optimize detection sensitivity and reduce variability.
- Support risk assessments for any proposed changes to inspection processes or inspection criteria.
Minimum Qualifications
- Extensive experience in GMP or regulated production environment, specifically in visual inspection
- Previous supervisory experience
- Knowledge of FDA cGMP’s
- Strong communication and leadership skills
- Problem solving skills
- Ability to direct and participate in cross-functional teams
- Strong working knowledge of GMPs, USP <790>/<1790>, Annex 1, and applicable FDA/EMA
- Excellent technical writing, presentation, and training skills
Preferred Qualifications
- Bachelor of Science in Engineering, Pharmacy, related Science, or business Experience working in
- Knowledge or previous experience in managing technical programs/projects
- Project management skills
- Experience with both manual and automated visual inspection systems
- Proficiency in defect categorization and defect documentation
- Experience managing a site’s Defect Lab and inspection training/qualification program.
- Proven experience supporting and defending inspection programs in regulatory audits
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.
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