Manufacturing Technician II, In-Line Inspector - Sterile Filling

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 The Manufacturing Technician II, In-Line Inspector supports sterile filling inspection operations, working in various Controlled/Non-Classified areas. The role also supports improvement activities such as 5S, problem-solving, Kaizen events, and manual data collection, all in accordance with cGMPs. Job Responsibilities Operations Accountable for the outgoing quality level of inspected product; perform manual visual, cosmetic, and physical inspection of material, promptly escalating concerns to the Lead and Manager/Supervisor. Must obtain and maintain visual inspection qualification. Operate assigned machinery, including servicing automated inspection equipment, monitoring equipment status, reintroducing materials, manually palletizing inspected materials, and assuring a smooth flow of product. Start up equipment, make minor adjustments to machinery, remove jams, and perform minor troubleshooting and assembly/disassembly for cleaning. Use material handling equipment such as motorized and manual pallet jacks and non-motorized lifts. Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment. Apply knowledge of product security controls. Perform work in accordance with SOPs, cGMPs, and OSHA-compliant safety procedures, maintaining familiarity with job-related hazards and controls (PPE, ergonomics, LOTO, human/material/waste/chemical handling, and spill control) and area chemical Safety Data Sheets. Report all discrepancies to the process facilitator. Print SOPs and forms via ECMS. Support lean and process-improvement activities, including 5S, problem-solving, and manual tracking of OEE performance data. Review operational SOPs, forms, and batch records for accuracy, and suggest process improvements while maintaining quality and cGMP compliance. Documentation & Compliance Perform batch record and GMP documentation entries; maintain records and logs as required, including mathematical computation where needed. Perform inventory control, reconciliation, and inventory movements using SAP in a limited role (e.g., moving items between storage locations and goods-issuing to process orders). Training & Development Acquire and maintain all required certifications and qualifications for the assigned work area, including cold room training/access to transfer materials in and out of the cold rooms. Cross-train and support other work areas as needed. Experience & Education Minimum Qualifications Prior experience in a regulated manufacturing environment (e.g., pharmaceutical, biotechnology, medical device, or other GMP-regulated industry) is preferred. Experience in manufacturing, quality, or visual inspection is highly desirable. Ability to effectively read, write, speak, and understand English to accurately interpret and follow Standard Operating Procedures (SOPs), batch records, work instructions, specifications, and other controlled documentation. Basic mathematical proficiency, including the ability to perform routine calculations involving weights, measures, percentages, and unit conversions, while accurately documenting inspection and production data. Ability to follow written procedures and standardized work with minimal supervision while recognizing abnormal conditions and appropriately escalating quality, safety, equipment, or process concerns. Strong attention to detail with the ability to identify product, process, or documentation discrepancies, maintain accurate documentation in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), and consistently adhere to quality standards. Basic problem-solving, organizational, and communication skills with the ability to work effectively both independently and collaboratively in a fast-paced manufacturing environment while supporting a culture of safety, quality, and continuous improvement. Preferred Qualifications High school graduate, vocational school graduate, or equivalent. 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations. Experience working in a lean manufacturing environment. Working knowledge of Microsoft applications, SAP and/or Veeva Vault. Physical & Work Environment Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning. This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP. Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.; ability to pass an eye exam during onboarding. Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing. Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc. All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. Work Schedule 12 hour - 2/2/3 Night Shift Schedule The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Sponsorship or support for work authorization Sponsorship or support for work authorization, including visas, is not available for this position. Equal Employment Opportunity Employer 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. Total Rewards 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Target base pay hiring range for this position is $21.50 - $32.00 per hour. 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. As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester. Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. #J-18808-Ljbffr Resilience