MSAT Engineer

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

We are seeking an MSAT Engineerto lead the transfer of pharmaceutical packaging and device assembly processes into manufacturing for sterile injectable products. This role will focus on development and implementation of robust secondary packaging manufacturing processes for prefilled syringes, autoinjectors, and other combination products, supporting technology transfer, process validation, commercial launch, and ongoing manufacturing operations.

Job Responsibilities

• Support technology transfer, process validation, GMP manufacturing support, and continued process activities for sterile injectable assembly and pharmaceutical packaging operations.
• Develop and implement manufacturing processes for autoinjector assembly, pharmaceutical packaging, and combination products from clinical development through commercialization.
• Collaborate directly with clients to understand manufacturing and packaging requirements and develop supporting technical documentation, including Technology Transfer Plans, Process Flow Diagrams (PFDs), Gap Assessments, Process FMEAs, Technical Summary Reports.
• Provide technical expertise in primary, secondary, and tertiary packaging development while managing project timelines and deliverables.
• Support packaging investigations, troubleshooting activities, root cause analyses, and implementation of corrective and preventive actions (CAPAs).
• Assist in the selection, qualification, and implementation of packaging materials and labeling solutions for new product introductions.
• Author and review GMP manufacturing documentation, including Master Batch Records (MBRs), Bills of Materials (BOMs), and manufacturing processing instructions.
• Monitor manufacturing and process performance data, identify trends, and recommend process improvements.
• Serve as a technical resource for device assembly and packaging processes while collaborating with cross-functional project teams and external customers.

Job Qualifications

• Bachelor's degree in Engineering, Packaging Technology, Life Sciences, or a related technical discipline.
• Experience supporting pharmaceutical packaging, combination products, or injectable device assembly within a regulated manufacturing environment.
• Knowledge of pharmaceutical packaging materials, packaging equipment, and manufacturing processes.
• Understanding of combination products, including autoinjector assembly and parenteral drug packaging.
• Experience supporting technology transfer and process validation activities.
• Understanding of combination product regulatory documentation, including Design History Files (DHF), Risk Management Files (RMF), Design Inputs, Design Outputs, and Design Transfer.