Process Engineer II: GMP Biomanufacturing & Optimization

Resilience; Northern (KY); Hybrid; USD 70,000 - 96,000; Full time

Benefits offered by this job

Annual bonus program

401(k) with company match

Healthcare (medical, dental, vision)

Job summary

Resilience is a technology-focused biomanufacturing company reinventing how medicines are made, building a high-tech, end-to-end manufacturing network to withstand disruptions and support scientific discovery. The Process Engineer II owns the technical process for IDAP equipment, collaborating with Manufacturing, Quality, Maintenance, and suppliers on projects with limited supervision.

Responsibilities include process validation, troubleshooting, and developing documentation to ensure compliant,

Qualifications

• Prior experience or exposure in a GMP or regulated manufacturing environment, with a demonstrated ability to follow controlled procedures and quality standards.
• Training or hands-on experience in IDAP-related technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control.
• Baseline proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
• Ability to work with limited supervision, exercising independent judgment on assigned processes.

Responsibilities

• Owns the technical process for assigned IDAP equipment; defines and maintains centerlines, critical process parameters, material fit for use, and operating procedures to ensure a capable, repeatable process.
• Drives continuous improvement for assigned IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
• Tracks equipment data, capabilities, utilization, efficiencies, and obsolescence for assigned assets; manages asset lifecycle and develops user requirements for new asset procurement.
• Provides engineering and project management for assigned projects, including developing project justification, tracking milestones, and informing capital planning.

Skills

Automation/Controls

Aseptic/Packaging equipment

Process/Materials

Maintenance

Validation

Education

Bachelor’s degree in Engineering or related science

Job description

Resilience is a technology-focused biomanufacturing company reinventing how medicines are made, building a high-tech, end-to-end manufacturing network to withstand disruptions and support scientific discovery. The Process Engineer II owns the technical process for IDAP equipment, collaborating with Manufacturing, Quality, Maintenance, and suppliers on projects with limited supervision.

Responsibilities include process validation, troubleshooting, and developing documentation to ensure compliant,