IDAP Process Engineer II: CI & Validation

National Resilience; United States; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Relocation Assistance

Job summary

Resilience is seeking a Process Engineer II to own the technical process for assigned IDAP equipment, ensuring capability, compliance, and continuous improvement. You will work with Manufacturing, Quality, Maintenance, and suppliers to resolve technical issues and deliver projects on time.

The role emphasizes driving validation, coordinating change controls, and writing critical documentation such as URS, FAT, SAT, IQ/OQ/PQ, and supporting regulatory inspections.

Qualifications

• Experience in GMP or regulated manufacturing with controlled procedures.
• Hands-on with IDAP technologies such as automation, hydraulics, pneumatics, vacuum, PLC, HMI, sterile environments.
• Proficient in at least one discipline: automation/controls, aseptic equipment, process/materials, maintenance, or validation.
• Ability to work with limited supervision.

Responsibilities

• Owns technical process for IDAP equipment; defines centerlines, critical process parameters, fit for use and SOPs.
• Drives continuous improvement for IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
• Leads validation activities; writes URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
• Manages change controls and risk assessments; supports regulatory inspections as process owner.

Skills

GMP exposure

IDAP tech

Independence

Automation/Controls

Validation

Education

Bachelor's degree in Engineering

Tools

PLC

HMI

Job description

Resilience is seeking a Process Engineer II to own the technical process for assigned IDAP equipment, ensuring capability, compliance, and continuous improvement. You will work with Manufacturing, Quality, Maintenance, and suppliers to resolve technical issues and deliver projects on time.

The role emphasizes driving validation, coordinating change controls, and writing critical documentation such as URS, FAT, SAT, IQ/OQ/PQ, and supporting regulatory inspections.