Process Engineer II — GMP Biomanufacturing & Optimization

Resilience

Port Union (OH)

On-site

USD 70,000 - 96,000

Full time

10 days ago

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Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare (medical, dental, vision)

Paid vacation and holidays

Tuition reimbursement

Job summary

Resilience in Ohio is seeking a Process Engineer II to own the technical process for IDAP equipment, drive improvements, and maintain validated state with limited supervision. You will partner with Manufacturing, Quality, Maintenance, and suppliers to deliver projects on time.

The role emphasizes validation, change control, and documentation such as URS, FAT, SAT, IQ/OQ/PQ, along with training and compliance.

Qualifications

GMP-exposed or regulated manufacturing background with adherence to quality standards.
Hands-on experience with IDAP technologies and related equipment.
Baseline proficiency in automation/controls, aseptic/packaging equipment, or validation.
Ability to work with limited supervision and exercise independent judgment.

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 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.
Leads validation activities for assigned processes, defining success criteria, confirming process capability, and maintaining validated state through change.
Authors and reviews URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned processes.
Troubleshoots assigned IDAP processes, diagnosing and resolving equipment and process deviations, including on-call support as required.
Works directly with equipment and material suppliers on assigned processes to resolve technical issues.
Identifies, develops, and manages implementation of change controls for assigned processes to improve performance and address root causes.
Performs and maintains risk management activities for assigned new and existing processes and equipment.
Initiates deviations and independently leads technical investigations and impact assessments for assigned processes.
Authors and reviews controlled documents including SOPs, Batch Records, and Rework procedures for assigned processes.
Supports regulatory inspections as the process owner for assigned IDAP equipment.
Identifies technical training requirements for Operations, Engineering, and Maintenance for assigned processes, and develops and delivers training materials.