MSAT Process Engineer – GMP & Tech Transfer

Alcami Corporation; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Alcami Corporation in Morrisville, NC is seeking a Process Engineer (MSAT, GMP, Tech Transfer) to drive technical transfer and support for clinical and commercial parenteral Drug Product manufacturing. The role requires on-site work, 1st shift, and collaboration with formulation development labs while following FDA and EU guidelines.

Responsibilities include writing Master Batch Records, validating processes, troubleshooting, and coordinating investigations and CAPAs to ensure cGMP compliance.

Qualifications

• Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field.
• Minimum 2 years of technical support and tech transfer in sterile pharmaceutical manufacturing.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with understanding of equipment, critical parameters, tests, etc.
• Monitors manufacturing processes during production runs and provides troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pfMEA risk assessment, and validation protocols.
• Identifies parameters, sampling, and tests used in validation protocols for new and existing products.
• Interacts with clients during scheduled project meetings.
• Ensures timely completion and compliance with cGMP and training requirements.

Skills

Tech transfer

cGMP knowledge

Documentation

Problem solving

Time management

Verbal comms

Written comms

Team collaboration

Education

Bachelors in Engineering/Pharmacy/Chemistry

Tools

Microsoft Office

Job description

Alcami Corporation in Morrisville, NC is seeking a Process Engineer (MSAT, GMP, Tech Transfer) to drive technical transfer and support for clinical and commercial parenteral Drug Product manufacturing. The role requires on-site work, 1st shift, and collaboration with formulation development labs while following FDA and EU guidelines.

Responsibilities include writing Master Batch Records, validating processes, troubleshooting, and coordinating investigations and CAPAs to ensure cGMP compliance.