MSAT Engineer: Packaging & Autoinjector Tech Transfer Lead

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Harba Solutions Inc. seeks an MSAT Engineer to lead transfer of pharmaceutical packaging and device assembly into manufacturing for sterile injectable products.

The role focuses on developing robust secondary packaging processes for prefilled syringes, autoinjectors, and other combination products, spanning tech transfer, validation, and commercial launch. You will collaborate with clients to document packaging workflows, create transfer plans, PFDs, and risk assessments, and provide technical

Qualifications

• Experience in pharmaceutical packaging, combination products, or injectable device assembly in a regulated setting.
• Knowledge of packaging materials, equipment, and manufacturing processes.
• Understanding of autoinjector assembly and parenteral drug packaging.
• Experience supporting technology transfer and process validation activities.
• Familiarity with DHF, RMF, Design Inputs/Outputs, and Design Transfer.

Responsibilities

• Support technology transfer, process validation, GMP manufacturing support, and continued process activities.
• Develop and implement manufacturing processes for autoinjector assembly and packaging from clinical development through commercialization.
• Collaborate with clients to understand requirements and develop documentation including Technology Transfer Plans, PFDs, and Gap Assessments.
• Provide technical expertise in primary, secondary, and tertiary packaging while managing timelines and deliverables.
• Support packaging investigations, CAPAs, and root cause analyses.
• Assist in selection and qualification of packaging materials and labeling solutions for new products.
• Author and review GMP documentation including MBRs, BOMs, and processing instructions.
• Monitor process performance data, identify trends, and propose improvements.
• Serve as a technical resource for device assembly and packaging across cross-functional teams.

Skills

pharma packaging

combination products

device assembly

regulated manufacturing

technology transfer

process validation

Education

Bachelor's degree in Engineering, Packaging Technology, Life Sciences, or related technical discipline

Job description

Harba Solutions Inc. seeks an MSAT Engineer to lead transfer of pharmaceutical packaging and device assembly into manufacturing for sterile injectable products.

The role focuses on developing robust secondary packaging processes for prefilled syringes, autoinjectors, and other combination products, spanning tech transfer, validation, and commercial launch. You will collaborate with clients to document packaging workflows, create transfer plans, PFDs, and risk assessments, and provide technical