Manufacturing Technician IV, Lead - Sterile Filling

Resilience; Olde West Chester (OH); Presencial; USD 36.000 - 56.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual cash bonus

401(k) plan with company match

Healthcare benefits

Descripción de la vacante

Resilience is a biomanufacturing technology company seeking a Manufacturing Technician IV, Lead to supervise filling operations on the production floor. You will act as a technical resource, review GMP documentation, and resolve complex production issues while ensuring compliance and quality.

The role requires significant pharma/biotech manufacturing experience, strong problem-solving skills, and the ability to train peers.

Formación

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Advanced knowledge of cGMP requirements, regulatory expectations, and quality systems.
• Ability to read, write, speak, and understand English to communicate complex technical information cross-functionally.
• Exceptional attention to detail with proven ability to review and ensure accuracy of critical documentation and records.
• Strong mathematical, analytical, and problem-solving skills to interpret data and drive solutions.
• Experience supporting investigations, root cause analysis, and CAPAs.
• Experience providing on-the-job training to peers while fostering a culture of compliance and CI.

Responsabilidades

• Lead and monitor process execution activities to ensure successful operations on the production floor.
• Serve as a technical resource; resolve complex production-related issues including batch setup, execution, and equipment operations.
• Provide support to production technicians and mechanical technicians.
• Apply organizational and problem-solving skills to guide team members on daily activities.
• Perform and execute filter integrity testing per SOP.
• Manage inventory control and reconciliation using SAP.

Conocimientos

cGMP compliance

Documentation

Problem solving

Quality systems

Audit support

English communication

Educación

High school diploma or equivalent

Herramientas

SAP

Veeva Vault

Descripción del empleo

Company Overview

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

Job Title

The Manufacturing Technician IV, Lead supports Filling operations. The position leads complex filling batch activities on the manufacturing floor, serves as a technical resource for the team, performs advanced-level documentation review, and resolves technical production issues.

Job Responsibilities

• Operations Lead and monitor process execution activities to ensure successful operations on the production floor.
• Serve as a technical resource for the team; resolve complex production-related issues including batch setup, execution, technical interventions, documentation, equipment operations, and safety/quality.
• Provide support to production technicians and mechanical technicians.
• Apply strong organizational and problem-solving skills to make independent decisions and provide guidance to team members on daily operational activities.
• Perform and execute filter integrity testing as needed per SOP.
• Perform technician tasks as required, including start-up, equipment operation, batch execution, material handling, and cleaning.
• Assemble, disassemble, and sanitize various Filling equipment.
• Assist technical staff with preventive maintenance procedures, as required.
• Manage inventory control and reconciliation activities using SAP.

Documentation & Compliance

Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy.

Training & Development

• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Support lean activities such as performing 5S and participating in problem-solving and CI projects.
• Attend and actively participate in daily tier meetings.

Experience & Education

Minimum Qualifications

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Advanced knowledge of cGMP requirements, regulatory expectations, and quality systems, including deviations, CAPAs, audits, and inspections.
• Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members.
• Ability to effectively read, write, speak, and understand English to communicate complex technical information cross-functionally.
• Exceptional attention to detail with proven ability to review and ensure accuracy of critical documentation and records.
• Strong mathematical, analytical, and problem-solving skills, with the ability to interpret data, identify trends, and drive solutions.
• Proven ability to support investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Experience providing on-the-job training to peers while fostering a culture of compliance and continuous improvement.
• Ability to manage own priorities, make informed decisions under pressure, and ensure production goals are met while maintaining regulatory compliance.
• Experience supporting audits and regulatory inspections, including interacting with internal and external auditors.
• 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.
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• 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 terminals, 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

12 Hour shifts, 2-2-3 schedule (Dayshift) 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

Sponsorship or support for work authorization, including visas, is not available for this position.

Equal Opportunity

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.

Benefits

• 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 $26.00 - $40.50 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.

Job Description Summary

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.

Company Profile

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.

Legal Notice

Please Note – 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.