Lead Manufacturing Technician: Filling & GMP Excellence

Resilience US; Olde West Chester (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Resilience US is seeking a Manufacturing Technician IV, Lead to drive filling operations on the production floor in a cGMP environment. You will lead complex batch activities, serve as a technical resource, review advanced batch records, and help resolve production-related issues.

The role requires strong adherence to regulatory expectations, excellent documentation practices, and capability to train peers while supporting continuous improvement and lean initiatives in a fast-paced facility.

Qualifications

• 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, 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 work effectively as part of a team in a fast-paced production environment.

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 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.
• 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.
• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians.
• Act as an 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.

Skills

Pharmaceutical manufacturing

cGMP compliance

Documentation accuracy

CAPA root cause analysis

Training others

Data interpretation

Audits & inspections

Problem-solving

Teamwork in fast-paced environment

Education

High school diploma or equivalent

Vocational training

Tools

SAP

Veeva Vault

Job description

Resilience US is seeking a Manufacturing Technician IV, Lead to drive filling operations on the production floor in a cGMP environment. You will lead complex batch activities, serve as a technical resource, review advanced batch records, and help resolve production-related issues.

The role requires strong adherence to regulatory expectations, excellent documentation practices, and capability to train peers while supporting continuous improvement and lean initiatives in a fast-paced facility.