Manufacturing Technician IV, Lead - Sterile Filling

Resilience; Port Union (OH); On-site; USD 36,000 - 56,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Comprehensive healthcare

Paid vacation and holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is a technology-focused biomanufacturing company seeking a Lead Manufacturing Technician IV focused on filling operations in West Chester. You will lead complex batch activities, act as a technical resource, and ensure rigorous documentation and GMP compliance.

The role requires strong problem-solving, data interpretation, and independent decision-making, with responsibilities spanning batch execution, equipment operation, and safety/quality. Competitive benefits apply.

Qualifications

• Significant experience in pharmaceutical/biotech or cGMP manufacturing.
• Advanced knowledge of cGMP requirements, regulatory expectations and quality systems.
• Ability to work independently and guide team members.
• Strong documentation accuracy and data interpretation skills.
• Experience supporting audits, CAPAs and investigations.

Responsibilities

• Lead complex filling batch activities on the production floor.
• Serve as a technical resource; resolve complex production issues and audit-ready documentation.
• Support technicians and preventive maintenance; assist with batch setup and equipment operation.
• Perform filter integrity testing per SOP and maintain equipment readiness.
• Manage inventory control and reconciliation in SAP; ensure compliance with GMP.
• Act as an on-the-job trainer; participate in 5S and CI projects; lead tier meetings.

Skills

Attention to detail

Mathematical ability

Analytical thinking

Problem solving

English communication

Lean manufacturing

Education

High school diploma or equivalent

Tools

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.comThe 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 ResponsibilitiesOperationsLead 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 & CompliancePerform 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 & DevelopmentServe 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 & EducationMinimum QualificationsSignificant 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 QualificationsHigh 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 EnvironmentWork 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 Schedule12 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 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 $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. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.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.