TSMS Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical manufacturing firm in Indianapolis is hiring a Technical Transfer Engineer to oversee technical transfer activities and ensure robust GMP manufacturing processes. The role involves managing documentation, troubleshooting processes, and providing cross-functional support. Candidates should have a Bachelor's in Science or Engineering and 2–3 years of relevant experience, ideally in a client-facing role. This position offers an opportunity to contribute to scalable manufacturing and lifecycle management while collaborating with various operational teams.

Qualifications

• 2–3 years of experience in a pharmaceutical manufacturing environment.
• Experience supporting technical transfer within pharmaceutical or related regulated industries.
• Client-facing role experience is preferred.

Responsibilities

• Lead and execute technical transfer activities for full-scale GMP manufacturing.
• Author and review GMP manufacturing documentation.
• Monitor and analyze process data for trends and performance control.
• Provide technical guidance during Process Performance Qualification.

Skills

Technical transfer

Process validation

GMP manufacturing

Troubleshooting

Education

Bachelor’s degree in Science or Engineering

Master’s degree in Science or Engineering (preferred)

Job description

The TSMS Technical Transfer Engineer supports the successful transfer, scale-up, and lifecycle management of clinical and commercial manufacturing processes in a cGMP environment. This role partners closely with Operations, Validation, Quality, and external customers to ensure manufacturing processes are robust, well-documented, and capable of reliable commercial execution.

The Technical Transfer Engineer provides hands-on technical support across tech transfer, process validation, GMP floor support, and continued process verification, serving as a key technical resource throughout the manufacturing lifecycle.

Responsibilities

• Lead and execute technical transfer activities, including process scale-up from development or client-provided data into full-scale GMP manufacturing
• Select appropriate manufacturing equipment and single-use components, and develop comprehensive technical documentation such as Tech Transfer Plans, Gap Assessments, Process Flow Diagrams, Summary Reports, and Process FMEAs
• Serve as a TSMS representative on cross-functional project teams and act as a technical point of contact for customers
• Author and review GMP manufacturing documentation, including Master Batch Records, Bills of Materials, and processing forms
• Monitor and analyze process data, identify trends, and recommend actions to maintain process control and performance
• Lead technical troubleshooting and investigations, including root cause analysis, product impact assessments, and CAPA development
• Provide technical guidance and oversight to Operations and Validation teams during Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
• Collaborate cross-functionally to assess, implement, and support new technologies within GMP manufacturing
• Evaluate and assess the impact of changes to product, process, equipment, materials, and procedures
• Manage timelines and prioritize critical tasks to support on-time project execution
• Perform additional duties as required to support manufacturing and project objectives

Qualifications

• Bachelor’s degree in Science or Engineering
• Master’s degree in Science or Engineering (preferred)
• 2–3 years of experience in a pharmaceutical manufacturing environment
• Experience supporting technical transfer within pharmaceutical, biotech, or related regulated industries in a client-facing role