Process Engineer III

BioSpace; Olde West Chester (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

An innovative biomanufacturing company is seeking a Process Engineer III to lead technical initiatives and improve manufacturing processes. This role involves collaborating with multiple teams, managing equipment data, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in GMP environments and experience with automation and controls. Join a forward-thinking organization that is transforming the production of medicine and making a significant impact on scientific discovery and patient care. This is an exciting opportunity to contribute to a sustainable future in healthcare.

Qualifications

• Experience in GMP or regulated production environments.
• Training in mechanics, hydraulics, pneumatics, and electronics.

Responsibilities

• Leads continuous process improvement efforts in automated pharmaceutical manufacturing.
• Coordinates and supports Manufacturing/Facility improvement initiatives.
• Acts as the key contact for regulatory inspections.

Skills

GMP or regulated production environments

Mechanics

Hydraulics

Pneumatics

Electronics

PLC programming

HMI systems

Computerized systems

Validation

Change control

Education

Bachelor's Degree in Engineering

Tools

Automation/controls

Aseptic/packaging equipment

Reporting systems

Job description

Join to apply for the Process Engineer III role at BioSpace.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com.

Brief Job Description

The Process Engineer III leads improvement initiatives as the technical expert and acts as the first line of support for all project-related work. Responsible for maintaining strong relationships with Technical Operations and Quality areas, collaborating within Manufacturing, the Facility, and with other Engineers. Serves as the single point of contact for all technical issues.

Position Summary & Responsibilities

• Ensures there is a single technical process with defined centerlines, critical process parameters, material fit for use, and operating procedures that deliver a capable process.
• Leads continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated pharmaceutical manufacturing equipment.
• Ensures success criteria for technology transfer and validation are clear and the process is capable for integration into Manufacturing/Facility processes.
• Generates URS, FAT, SAT, commissioning, IQ/OQ/PQ protocols/reports.
• Coordinates and supports Manufacturing/Facility improvement initiatives, managing equipment data, capabilities, utilization, efficiencies, and asset lifecycle.
• Maintains external technical relationships and collaborates with equipment and material suppliers.
• Identifies, develops, and manages implementation of change controls to improve processes and address root causes.
• Performs risk management activities for new and existing processes/equipment.
• Initiates deviations and conducts technical investigations and impact assessments.
• Authors and reviews SOPs, Batch Records, Rework procedures, validation, and change control documents.
• Provides input for new asset procurement and develops user requirements.
• Provides engineering and project management services, including project justification and proposals.
• Supports technical training for Operations/Engineering/Maintenance.
• Performs routine validation and reviews activities.
• Supports and leads troubleshooting efforts.
• Provides on-call support as required.
• Acts as the key contact for regulatory inspections as the technical process owner.
• Participates in annual product review and biennial critical systems review processes.
• Responsible for process validation related to changes in validated processes within Manufacturing.

Minimum Qualifications

• Experience in GMP or regulated production environments.
• Training or experience in mechanics, hydraulics, pneumatics, vacuum technology, electronics, PLCs, HMI, reporting systems, computerized systems, vision systems, refrigeration, electrical/mechanical troubleshooting, aseptic environments, unit operations, formulation, packaging, validation, technology transfer, change control, and applied statistics.
• Proficiency in automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.

Preferred Qualifications

• Bachelor’s Degree in Engineering or related science.
• Project management experience.
• Insightful approach to challenging and adapting current methods.
• Six Sigma or analytical troubleshooting skills.
• Experience in LEAN manufacturing environments.
• Expertise in multiple disciplines such as automation, aseptic/packaging, process/materials, maintenance, validation.
• Ability to coach and mentor peers.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, veteran status, disability, genetic information, or other protected characteristics.