Manufacturing Technician IV, Lead - DAP (Nights)

Resilience US; Olde West Chester (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Resilience US is seeking an Operations professional to lead complex production activities, ensure strict GMP compliance, and support training for the packaging floor. The role requires strong documentation skills and independent problem-solving in a fast-paced biomanufacturing environment.

The candidate will interact with management and engineers on packaging initiatives, maintain certifications, and lead daily Tier 0 meetings to drive continuous improvement.

Qualifications

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Advanced knowledge of cGMP requirements and quality systems, including deviations, change control, and data integrity.
• Ability to work independently and resolve complex production issues in a fast-paced setting.
• Proven ability to review and ensure accuracy of GMP documentation and batch records.
• Able to read, write, and communicate technical information in English cross-functionally.

Responsibilities

• Lead and monitor complex process activities on the production floor to ensure successful operations.
• Perform technician tasks including start-up, equipment operation, packaging, and line clearances.
• Use SAP and WES for inventory control and reconciliation.
• Execute protocols for equipment qualification and process validation.
• Ensure compliance with SOPs and cGMPs on the production floor.
• Support lean activities such as 5S and CI projects.

Skills

cGMP knowledge

Documentation accuracy

Independence

Analytical thinking

Problem solving

Teamwork

English communication

Education

High school diploma or equivalent

4+ years in pharma/manufacturing environment

Tools

SAP

Veeva Vault

Claude (AI tools)

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

Job Responsibilities

Operations

• Lead and monitor complex process activities to ensure successful operations on the production floor.
• Perform technician tasks as required including start-up, equipment operation, manual packaging, and line clearances.
• 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.

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.
• Review process documents such as operational SOPs, forms, and batch records for accuracy; propose revisions and update documents where needed.
• Maintain all required certifications and qualifications for the assigned work area.

Training & Development

• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Collaborate with Management and Engineers on packaging floor initiatives.
• Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily operational activities.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Prepare and lead daily Tier 0 meetings.

Experience & Education

Minimum Qualifications

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Advanced knowledge of cGMP requirements and quality systems, including deviations, change control, and data integrity.
• Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members in a fast-paced production environment.
• Proven ability to review and ensure accuracy of critical GMP documentation and batch records.
• Demonstrated ability to work with limited supervision and independently determine daily priorities, with strong organizational, analytical, and problem-solving skills to make informed decisions under pressure.
• Applied quantitative skills sufficient to interpret production data, evaluate trends, and support investigations and continuous improvement work.
• Experience providing on-the-job training to peers in a manufacturing environment.
• Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally.
• 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.
• Prior experience serving as a subject-matter resource or trainer on the production floor.
• Experience in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault and generative AI language tools such as Claude.

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 Proce