Manufacturing Technician IV, Lead - Inspection

Resilience, Inc.; Blue Ash (OH); Vor Ort; USD 36.000 - 56.000; Vollzeit

Benefits dieser Stelle

Annual cash bonus

401(k) plan with company match

Great healthcare package

Paid vacation

Paid holidays

Tuition reimbursement

Caregiving support

Zusammenfassung

Resilience, Inc. is hiring on-site in the United States for an experienced inspector on the production floor. You will lead inspection activities, ensure compliance with SOPs and cGMPs, and support documentation, training, and process improvements across the manufacturing line.

You will collaborate with Process Facilitators and Engineers, maintain certifications, and serve as a technical resource while following health and safety protocols and Lean practices.

Qualifikationen

• Significant experience in a pharmaceutical, biotechnology, or cGMP‑regulated manufacturing environment.
• Expertise across inspection types and equipment.
• Knowledge of cGMP requirements, inspection processes, and documentation practices.
• Ability to read, write, and discuss technical information in English.
• Experience providing on‑the‑job training or technical guidance.

Aufgaben

• Lead and monitor inspection process activities on the production floor.
• Perform inspection activities to support floor coverage and qualification maintenance.
• Perform inventory control and reconciliation using SAP and WES.
• Execute protocols for equipment qualification and process validation.
• Ensure compliance with SOPs and cGMPs on the production floor.
• Support Lean activities including 5S and problem-solving as a CI resource.
• Maintain batch records and GMP documentation with guidance to team.

Kenntnisse

Pharma manufacturing

cGMP knowledge

Inspection processes

Documentation accuracy

English communication

On-the-job training

Team collaboration

Problem solving

Ausbildung

High school diploma or equivalent

Tools

SAP

Veeva Vault

Jobbeschreibung

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

Job Responsibilities

• Operations: Lead and monitor inspection process activities to ensure successful operations on the production floor.
• Operations: Perform inspection activities as needed to support floor coverage and qualification maintenance.
• Operations: Perform inventory control and reconciliation activities using SAP and WES.
• Operations: Execute protocols as required as part of equipment qualification and process validation work.
• Operations: Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.
• Operations: 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.
• Documentation & Compliance: Access and print SOPs and forms via ECMS as required, using current revisions.
• Documentation & Compliance: Follow job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Documentation & Compliance: 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.
• Training & Development: Serve as a technical resource for the team, providing subject‑matter guidance to production and mechanical technicians.
• Training & Development: Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Training & Development: Support team members in maintaining required qualifications and certifications.
• Training & Development: Collaborate with Process Facilitators and Engineers on inspection floor initiatives.
• Training & Development: Apply strong problem‑solving and prioritization skills to make independent decisions and provide guidance to team members on daily production activities.
• Training & Development: Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Training & Development: Attend and actively participate in daily Tier1 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.
• Minimum Requirements: Significant experience in a pharmaceutical, biotechnology, or cGMP‑regulated manufacturing environment, including knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Minimum Requirements: Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Minimum Requirements: Strong organizational, analytical, and problem‑solving skills with the ability to independently prioritize operations.
• Minimum Requirements: Ability to effectively read, write, speak, and understand English to communicate technical information cross‑functionally.
• Minimum Requirements: Experience providing on‑the‑job training or technical guidance to peers while fostering a culture of compliance and continuous improvement.
• Minimum Requirements: 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.
• Preferred Background: 4+ years of experience in a pharmaceutical, biotechnology, or cGMP‑regulated manufacturing environment.
• Preferred Background: Prior inspection experience.
• Preferred Background: Experience in metrics tracking and reporting.
• Preferred Background: Experience contributing to inspection process improvements, deviation investigations, and qualification programs.
• Preferred Background: Experience working in a lean manufacturing environment.
• Preferred Background: 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 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 Schedule

This position will start on a M-F 8 hour project schedule then transition to a 2-2-3 rotating 12 hour 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

Sponsorship or support for work authorization, including visas, is not available for this position.

Equal Employment Opportunity Employer

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.

Benefits and Total Rewards

• Resilience offers employees a robust total rewards program including an annual cash bonus program
• 401(k) plan with a generous company match
• 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
• 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.

Company Overview

Resilience is a first‑of‑its‑kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high‑tech, end‑to‑end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.