Manufacturing Engineer – GMP Biotech & Aseptic

Harba Solutions Inc.; Fishers (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Harba Solutions Inc. is seeking a Manufacturing Engineering Technician to uphold data integrity, apply advanced digital technologies, and support GMP manufacturing in a highly regulated environment.

The role emphasizes aseptic filling, sterile manufacturing, and engineering principles within the pharmaceutical/biotech sectors. You will troubleshoot, perform maintenance, drive continuous process improvements, and mentor manufacturing personnel while owning the equipment tracking process and

Qualifications

• Bachelor’s degree in engineering field, or life sciences with 5+ years of relevant work experience.
• Or 10+ years of relevant work experience.
• Ability to become a SME for aseptic filling, inspection and packaging equipment.

Responsibilities

• Resolve issues that arise in day-to-day running of operations, providing timely responses and solutions.
• Implement solutions in collaboration with cross-functional technical teams and site leadership team.
• Evaluate and improve efficiency of manufacturing instruments, equipment, and tools.
• Evaluate and implement new changes.
• Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Provide technical support to manufacturing activities.
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
• Partner with vendors and suppliers to define requirements and understand functional specifications.
• Work flexible hours to ensure production facility coverage.

Skills

Process design

Data integrity

Instrumentation

Controls

Electro-mechanical systems

Education

Bachelor's degree in engineering

Job description

Harba Solutions Inc. is seeking a Manufacturing Engineering Technician to uphold data integrity, apply advanced digital technologies, and support GMP manufacturing in a highly regulated environment.

The role emphasizes aseptic filling, sterile manufacturing, and engineering principles within the pharmaceutical/biotech sectors. You will troubleshoot, perform maintenance, drive continuous process improvements, and mentor manufacturing personnel while owning the equipment tracking process and