Maintenance Technician IV, Lead - Sterile Operations (Night Shift)

Resilience; Olde West Chester (OH); On-site; USD 39,261 - 64,058; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare

Job summary

Resilience is seeking a Manufacturing Technician IV, Lead to oversee filling operations on the production floor. You will lead complex batch activities, serve as a technical resource, and review documentation for accuracy in a cGMP setting.

You will train teammates, participate in lean activities, and ensure regulatory compliance while supporting 12‑hour night shifts in a fast-paced biomanufacturing environment.

Qualifications

• Significant experience in pharmaceutical/biotech or cGMP manufacturing.
• Strong knowledge of cGMP requirements and quality systems.
• Ability to read/write/speak English to communicate technical information.

Responsibilities

• Lead and monitor process execution on the production floor.
• Serve as technical resource; resolve complex production issues and ensure documentation accuracy.
• Provide support to technicians and assist with preventive maintenance.

Skills

Pharma manufacturing

Analytical skills

Documentation accuracy

Team guidance

Problem solving

Education

High school diploma or equivalent

Tools

SAP

Veeva Vault

Job description

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.

Job Overview

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.

Responsibilities

• 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 and mechanical technicians and assist with preventive maintenance procedures.
• 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.
• Manage inventory control and reconciliation activities using SAP.
• 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.
• 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.

Required 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 per SOP. Visual acuity requirements include data reading, computer terminal operation, extensive reading, machinery operation, and general facility observations. Participation in an occupational health program is required (medical assessment, surveillance, vaccination, and testing). Personal protective equipment usage may include respirators, PAPRs, gowns, gloves, face protection, and other barrier equipment. All employees must adhere to the Quality Management System established by the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and applicable regulations. Employees must pass an eye exam during onboarding.

Work Schedule

Night shift position working 6pm–6:30am on a 12‑hour rotation of 2 nights on, 2 nights off, 3 nights on, and 3 nights off. The schedule listed reflects the expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including overtime requests, with or without notice, based on business needs. No guarantee of specific hours, days, or shift assignments.

EEO Statement

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 other non‑job‑related characteristics or 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 a comprehensive benefits package (healthcare including medical, dental, vision; family building benefits; life and disability insurance; paid vacation; paid holidays; other paid leaves of absence; tuition reimbursement; and caregiving support). The target base pay hiring range for this position is $28.50–$46.50 per hour.

Additional Information

Sponsorship or support for work authorization, including visas, is not available for this position. As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. The company does not accept unsolicited agency resumes. Resilience will not pay any third‑party agency or company without a signed agreement.