Harba Solutions Inc. is hiring: Manufacturing Engineer in Indianapolis

The Manufacturing Engineer is a critical member of the Technical Operations team, responsible for supporting reliable GMP manufacturing through strong engineering practices and process expertise. This role focuses on maintaining data integrity, driving process improvements, and supporting the adoption of advanced technologies across sterile and aseptic manufacturing operations.

Position Summary

Harba Solutions Inc. provided pay range: $90,000.00/yr - $110,000.00/yr, with additional compensation types including Annual Bonus.

Responsibilities

• Serve as a technical subject matter expert for aseptic filling systems and related manufacturing equipment.
• Respond to and resolve daily production challenges, ensuring timely solutions and minimal disruption to operations.
• Collaborate with cross-functional partners and site leadership to implement corrective actions and long-term improvements.
• Analyze equipment performance and implement efficiency and reliability enhancements.
• Lead and support risk assessments (e.g., FMEA) to identify potential issues prior to validation and process qualification.
• Provide direct technical support for manufacturing operations while ensuring compliance with cGMP and Good Engineering Practices (GEP).
• Partner with external vendors and suppliers to define requirements, review specifications, and support equipment implementation.
• Support digitalization and process control initiatives that align with the site’s technology strategy.
• Work flexible schedules as required to maintain coverage for round-the-clock manufacturing operations.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field, with 5+ years of relevant experience.
• Proven background in pharmaceutical or biotechnology manufacturing, with hands-on experience in aseptic filling and sterile processing.
• Strong troubleshooting skills and practical experience with preventative maintenance and repair of production equipment.

Preferred Qualifications

• Lean Six Sigma certification or equivalent continuous improvement training.
• Solid understanding of regulatory requirements for GMP manufacturing of pharmaceuticals and biologics.
• Practical knowledge of process design, automation/controls, data integrity, and instrumentation systems.

Offering benefits including medical insurance, vision insurance, and 401(k). This is a full-time, mid-senior level position in Engineering, Manufacturing, and Project Management.