Maintenance Technician IV, Lead - Sterile Operations; Night Shift

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.

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.

• 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.

• 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.

• 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.