Senior Process Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Harba Solutions Inc. is seeking a Senior Process Engineer to drive the expansion of automated syringe device assembly and packaging operations, ensuring CQV readiness, GMP compliance, and regulatory alignment across the manufacturing line.

You will lead commissioning, qualification and process validation of new equipment, coordinate with OEMs and cross-functional teams, and mentor engineers to deliver scalable production capabilities for prefilled syringes, autoinjectors and serialization.

Qualifications

• Bachelor's degree in Engineering or related field.
• 10+ years of engineering experience in pharmaceutical manufacturing, medical device manufacturing, or related regulated industry.
• Strong experience with automated assembly, packaging, or inspection equipment in a GMP environment.
• Hands-on experience with commissioning, qualification, process validation, and FAT/SAT activities.

Responsibilities

• Lead the commissioning, qualification, and process validation of new automated assembly and packaging equipment.
• Manage equipment onboarding activities from design review and FAT/SAT through production startup and lifecycle support.
• Partner with equipment OEMs, vendors, manufacturing, quality, and engineering teams to implement new technologies and process improvements.
• Develop and execute CQV documentation, process validation protocols, and equipment performance strategies.
• Provide technical ownership for automated autoinjector assembly, top-load cartoning, and serialization systems.
• Support troubleshooting, investigations, and optimization of manufacturing processes to improve equipment reliability and performance.
• Participate in capital projects involving the expansion of assembly and packaging capabilities.
• Mentor junior engineers and provide technical leadership across cross-functional project teams.
• Ensure all activities are performed in compliance with GMP and regulatory expectations.

Skills

Commissioning

Process validation

Automation

Vendor management

GMP

Education

Bachelor's degree in Engineering

Job description

We are seeking a Senior Process Engineer to support the expansion of advanced pharmaceutical syringe device assembly and packaging operations. This role will focus on the introduction, qualification, and lifecycle support of highly automated manufacturing equipment used for prefilled syringe assembly, autoinjector integration, cartoning, and serialization. The engineer will work closely with equipment manufacturers, manufacturing operations, quality, and cross-functional teams to deliver new production capabilities while ensuring compliance with pharmaceutical industry standards.

Job Responsibilities

• Lead the commissioning, qualification, and process validation of new automated assembly and packaging equipment.
• Manage equipment onboarding activities from design review and FAT/SAT through production startup and lifecycle support.
• Partner with equipment OEMs, vendors, manufacturing, quality, and engineering teams to implement new technologies and process improvements.
• Develop and execute CQV documentation, process validation protocols, and equipment performance strategies.
• Provide technical ownership for automated autoinjector assembly, top-load cartoning, and serialization systems.
• Support troubleshooting, investigations, and optimization of manufacturing processes to improve equipment reliability and performance.
• Participate in capital projects involving the expansion of assembly and packaging capabilities.
• Mentor junior engineers and provide technical leadership across cross-functional project teams.
• Ensure all activities are performed in compliance with GMP and regulatory expectations.

Job Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 10+ years of engineering experience in pharmaceutical manufacturing, medical device manufacturing, or a closely related regulated industry.
• Strong experience with automated assembly, packaging, or inspection equipment in a GMP environment.
• Hands-on knowledge of commissioning, qualification, process validation, and FAT/SAT activities.
• Experience working directly with equipment vendors and managing new equipment implementation projects.
• Familiarity with automated syringe assembly, autoinjector systems, cartoning, serialization, or similar packaging technologies is highly preferred.