Senior Process Engineer - MSAT & Tech Transfer (Onsite)

Alcami Corporation; Morrisville (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

Alcami Corporation in Morrisville, NC, USA, seeks a Sr. Process Engineer (MSAT, GMP, Tech Transfer) to drive tech transfer and validation activities for clinical and commercial parenteral drug products.

The role requires 5 years in sterile pharmaceutical manufacturing, strong process documentation, and experience with FDA/EU GMP standards. On-site, Monday–Friday, with potential domestic travel up to 5%.

Qualifications

• Bachelor's degree in Engineering, Pharmacy, or Chemistry.
• 5 years of experience in a sterile pharmaceutical manufacturing environment.
• Experience supporting tech transfer of parenteral Drug Products preferred.

Responsibilities

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with understanding of equipment, critical process parameters, in-process tests, etc.
• Monitors manufacturing processes during production runs to address technical issues and provide troubleshooting.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
• Identifies parameters, sampling, and tests used in validation protocols of new and existing products.
• Interacts with clients during project meetings and ensures compliance with cGMP and training requirements.

Skills

Communication

Documentation

Analytical thinking

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Pharmacy, or Chemistry

Tools

Microsoft Office

Job description

Alcami Corporation in Morrisville, NC, USA, seeks a Sr. Process Engineer (MSAT, GMP, Tech Transfer) to drive tech transfer and validation activities for clinical and commercial parenteral drug products.

The role requires 5 years in sterile pharmaceutical manufacturing, strong process documentation, and experience with FDA/EU GMP standards. On-site, Monday–Friday, with potential domestic travel up to 5%.