Senior Process Engineer - Parenteral Drug Product, On-Site

Alcami Corporation; North Charleston (SC); On-site; USD 110,000 - 170,000; Full time

Job summary

Alcami Corporation is seeking a Sr. Process Engineer to drive technical support for clinical and commercial parenteral Drug Product manufacturing. The role includes tech transfers, process validation support, and batch manufacturing documentation in a fast-paced, regulated environment.

The ideal candidate will perform deviations and investigations while coordinating lab studies with formulation development and ensuring cGMP compliance and training requirements are met.

Qualifications

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

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 provides troubleshooting.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and validation protocols.
• Interacts with clients during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and training requirements.

Skills

Process engineering

Tech transfer

Documentation

Analytical thinking

Communication skills

Education

Bachelor’s degree in Engineering/Pharmacy/Chemistry

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Sr. Process Engineer to drive technical support for clinical and commercial parenteral Drug Product manufacturing. The role includes tech transfers, process validation support, and batch manufacturing documentation in a fast-paced, regulated environment.

The ideal candidate will perform deviations and investigations while coordinating lab studies with formulation development and ensuring cGMP compliance and training requirements are met.