Manufacturing Technician IV, Lead - Inspection

Resilience US; Blue Ash (OH); On-site; USD 90,000 - 115,000; Full time

Job summary

Resilience US is seeking a Manufacturing Technician IV, Lead to supervise inspection activities on the production floor and serve as a technical resource for the team. You will review complex documentation, maintain qualification standards, and partner with Process Facilitators and Engineers to drive continuous improvement.

The role emphasizes adherence to cGMPs, SOPs, and safety procedures while leading training and supporting deviation investigations and CAPA efforts on the inspection floor.

Qualifications

• Significant experience in pharmaceutical/biotech manufacturing.
• Experience with inspection types and equipment.
• Ability to read, write, and communicate in English cross-functionally.
• Experience providing on-the-job training or technical guidance to peers.

Responsibilities

• Lead and monitor inspection activities to ensure production floor success.
• Perform inspection duties to support floor coverage and qualification maintenance.
• Manage inventory control and reconciliation using SAP and WES.
• Execute equipment qualification and process validation protocols.
• Ensure SOPs and cGMPs are followed on the production floor.
• Support lean activities and CI initiatives on the Process Execution Team (PET).

Skills

Leadership

Inspection expertise

Documentation accuracy

Problem-solving

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.com

The Manufacturing Technician IV, Lead

Lead reports to a Supervisor/Manager on the Manufacturing floor and leads complex Inspection floor activities. The Technician serves as a technical resource for the team, performs advanced-level documentation review, maintains qualification standards, and drives continuous improvement in partnership with Process Facilitators and Engineers.

Job Responsibilities

Operations:

• Lead and monitor inspection process activities to ensure successful operations on the production floor.
• Perform inspection activities as needed to support floor coverage and qualification maintenance.
• Perform inventory control and reconciliation activities using SAP and WES.
• Execute protocols as required as part of equipment qualification and process validation work.
• Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.
• Support lean activities including 5S, problem-solving, and serving as CI project resource for the Process Execution Team (PET).

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.
• Access and print SOPs and forms via ECMS as required, using current revisions.
• Follow job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Use process documents including SOPs, forms, and batch records to guide own work in accordance with SOPs and cGMPs.

Training & Development:

• Maintain all required certifications and qualifications for the assigned work area.
• Serve as a technical resource for the team, providing subject-matter guidance to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Support team members in maintaining required qualifications and certifications.
• Collaborate with Process Facilitators and Engineers on inspection floor initiatives.
• Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily production activities.
• Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Attend and actively participate in daily Tier 1 meetings.

Education & Experience

Minimum Requirements:

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including demonstrated expertise across all inspection types and equipment and prior experience leading floor execution.
• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Strong organizational, analytical, and problem-solving skills with the ability to independently prioritize operations.
• Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally.
• Experience providing on-the-job training or technical guidance 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.

Preferred Background:

• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Prior inspection experience.
• Experience in metrics tracking and reporting.
• Experience contributing to inspection process improvements, deviation investigations, and qualification programs.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment

This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.

Visual acuity such as working with data & figures, viewing computer terminal, 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 protectio