Manufacturing Engineer

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

The Manufacturing Engineering Technician is a key technical role within Engineering and Technical Operations to ensure data integrity, implement state-of-the-art digital technologies, process control strategies, and support the technology road map. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling, sterile manufacturing, and engineering principles.

The Manufacturing Engineering Technician will have the demonstrated ability to apply experience to process design, design thinking, data integrity, controls, instrumentation, and electro-mechanical systems.

The ideal candidate must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment while providing high level support to the process engineering and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes. You will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of our product. You will also be expected to demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking. Additionally, this position would act as the owner of the equipment tracking process for manufacturing equipment.

Essential Job Functions:

• 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.

Special Job Requirements:

• 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.

Additional Preferences:

• Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development.