Process Engineer II — GMP Automation & Process Optimization

Resilience; Blue Ash (OH); Sur place; USD 70 000 - 96 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental & Vision

Life insurance

Paid vacation

Tuition reimbursement

Caregiving support

Résumé du poste

Resilience is seeking a Process Engineer II to own the technical process for IDAP equipment, drive continuous improvement, and lead validation and change control activities. You will collaborate with Manufacturing, Quality, Maintenance, and suppliers to deliver projects on time and ensure compliant, capable processes.

Preferred candidates have GMP exposure, IDAP-related tech experience, and a background in process or packaging equipment validation, with 2+ years in regulated pharma environments.

Qualifications

• GMP or regulated manufacturing experience required.
• IDAP technologies experience or exposure, incl. mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, or vision systems.
• Bachelor's degree in Engineering or related science; 2+ years in GMP manufacturing preferred.
• Experience with project management and process-improvement methodologies (Six Sigma, Lean).

Responsabilités

• Owns the technical process for assigned IDAP equipment and maintains centerlines, CP parameters, and operating procedures.
• Leads validation activities and documents URS, FAT, SAT, IQ/OQ/PQ for processes.
• Identifies and manages change controls, risk assessments, investigations, and deviations for assigned processes.
• Develops and delivers training materials for Operations, Engineering, and Maintenance.
• Supports regulatory inspections and collaborates with suppliers on technical issues.

Connaissances

Automation/Controls

Maintenance

Validation

Change control

Six Sigma

Lean

PLC/SCADA

HMI

Formation

Bachelor's degree in Engineering or related science

Outils

IDAP equipment tech

Aseptic/packaging equipment

PLC hardware

Description du poste

Resilience is seeking a Process Engineer II to own the technical process for IDAP equipment, drive continuous improvement, and lead validation and change control activities. You will collaborate with Manufacturing, Quality, Maintenance, and suppliers to deliver projects on time and ensure compliant, capable processes.

Preferred candidates have GMP exposure, IDAP-related tech experience, and a background in process or packaging equipment validation, with 2+ years in regulated pharma environments.