Manufacturing Technician III - Sterile Filling

Resilience; Olde West Chester (OH); On-site; USD 33,000 - 52,000; Full time

Benefits offered by this job

Annual bonus program

401(k) plan with company match

Healthcare benefits (medical, dental,

Paid vacation and holidays

Tuition reimbursement and caregiving支持

Job summary

Resilience seeks a Manufacturing Technician III to operate filling equipment in sterile and aseptic areas on the Ohio site, ensuring product flow and quality. You will perform in-process monitoring, participate in media fills, and mentor Tech II staff while maintaining rigorous cGMP standards.

The role requires strong attention to detail, teamwork in a fast-paced setting, and experience with SAP or Veeva Vault.

Qualifications

• Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Independent execution of filling procedures and adherence to quality systems.
• Strong reading/writing/speaking English for technical communication.
• Attention to detail with accuracy in batch records and documentation.
• Experience mentoring or training technicians and onboarding new staff.
• Understanding of deviation reporting, change control, and data integrity principles.

Responsibilities

• Operate assigned filling machinery, service equipment, and ensure smooth product flow.
• Assemble, disassemble, operate, and sanitize Filling equipment and perform start-up adjustments.
• Conduct in-process monitoring and validate filter integrity per SOP.
• Enter data online, including SCADA/HMI entries, and perform SAP transactions as needed.
• Demonstrate aseptic technique and participate in media fills and line interventions.
• Maintain cGMP documentation, batch records, and quality documentation.
• Support lean activities and process improvement, including 5S and problem-solving.
• Cross-train and mentor Tech II team members; maintain certifications and qualifications.

Skills

cGMP compliance

English proficiency

Data entry

Education

High school diploma or equivalent

Tools

Microsoft applications

SAP

Veeva Vault

Job description

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 Manufacturing Technician III reports to a Supervisor/Manager on the Manufacturing floor, supporting Filling (Sterile) operations. This position requires working in Controlled/Non-Classified and Classified areas. The Technician independently operates filling equipment, demonstrates advanced aseptic technique, performs in-process monitoring, and mentors Tech II team members.

Job Responsibilities

• Operations Independently perform the duties of operating all assigned machinery: servicing filling machines with materials, removing finished materials from machine tables, and assuring smooth product flow.
• Assemble, disassemble, operate, and sanitize various Filling equipment.
• Perform and execute filter integrity testing as needed per SOP.
• Start-up equipment and make minor adjustments as needed.
• Enter data online as required, including SCADA and HMI entries.
• Work with various printing devices, including printing mats.
• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
• Perform visual and physical checks of in-process and finished materials as requested.
• Demonstrate advanced aseptic technique; lead and participate in media fills, including line interventions; apply working knowledge of viable and non-viable environmental monitoring.
• Assist mechanical staff with preventive maintenance procedures, as required.
• Assist with executing Validation/Engineering protocols for processes and equipment.
• Support lean activities and process improvement work, such as performing 5S and participating in problem-solving.
• Perform SAP transactions as required at an intermediate level of knowledge.

Documentation & Compliance

• Complete batch record and GMP documentation entries; independently review own documentation for accuracy before submission.
• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.

Training & Development

• Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate Tech II team members.
• Maintain all required certifications and qualifications for the assigned work area.
• Cross-train and support other work areas as needed.
• Attend and actively participate in daily tier meetings.

Experience & Education

Minimum Qualifications

• Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including independent execution of filling procedures.
• Strong working knowledge of cGMP regulations, including deviation reporting, change control, and data integrity principles.
• Proven ability to independently execute complex procedures and troubleshoot routine process or equipment issues.
• Ability to effectively read, write, speak, and understand English to interpret technical documents and clearly communicate cross-functionally.
• High level of attention to detail with demonstrated accuracy in completing and reviewing batch records and controlled documentation.
• Proficient mathematical and analytical skills, including performing calculations related to manufacturing processes and verifying results.
• Experience mentoring or training technicians and supporting onboarding of new team members.
• Ability to identify process improvements and contribute to continuous improvement initiatives.
• Strong organizational skills and the ability to prioritize tasks while maintaining compliance and production timelines.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 2+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Prior aseptic manufacturing experience.
• 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.
• 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.
• Ability to pass eye exam during onboarding.

Work Schedule

[examples: 8 hours - Monday- Friday; 10 hours – Monday-Thursday; 12 hour – 2/2/3] 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, including visas, is not available for this position.

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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Our target base pay hiring range for this position is $24.00 - $38.00 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 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.