Process Engineer II (Relocation Assistance)

Resilience•Blue Ash, OH

2d•$70,000 - $96,250

About The Position

The Process Engineer II owns the technical process for assigned IDAP equipment, working with limited supervision to keep processes capable, compliant, and continuously improving. The role drives process improvement, validation, and troubleshooting; authors controlled documentation; and partners with Manufacturing, Quality, Maintenance, and equipment suppliers to resolve technical issues and deliver projects on time. The position manages assigned equipment processes and asset lifecycles, leads validation and technical investigations, supports quality systems and regulatory inspections, and identifies and delivers training for Operations, Engineering, and Maintenance. Work may involve extended hours, including evenings and weekends, depending on deadlines and operational needs, as well as occasional travel. The stated schedule is eight hours, Monday through Friday, and may be modified to meet business needs.

Requirements

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

Nice To Haves

Bachelor's degree in Engineering or a related science.
Two or more years of experience in a GMP or regulated pharmaceutical manufacturing environment.
Experience with project management and process-improvement methodologies such as Six Sigma or Lean.
Expertise in at least one discipline: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.

Responsibilities

Own the technical process for assigned IDAP equipment, defining and maintaining centerlines, critical process parameters, material fit for use, and operating procedures.
Drive continuous improvement, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
Track equipment data, capabilities, utilization, efficiencies, and obsolescence; manage asset lifecycle and develop user requirements for new asset procurement.
Provide engineering and project management for assigned projects, developing project justification, tracking milestones, and informing capital planning.
Lead validation activities, define success criteria, confirm process capability, and maintain validated state through change.
Author and review URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
Troubleshoot assigned processes and resolve equipment and process deviations, including on-call support as required.
Work with equipment and material suppliers to resolve technical issues.
Identify, develop, and manage implementation of change controls to improve performance and address root causes.
Perform and maintain risk management activities for assigned processes and equipment.
Initiate deviations and lead technical investigations and impact assessments.
Author and review controlled documents, including SOPs, Batch Records, and Rework procedures.
Support regulatory inspections as process owner for assigned IDAP equipment.
Identify technical training requirements and develop and deliver training materials for Operations, Engineering, and Maintenance.