Senior Process Engineer - Parenteral Tech Transfer

Alcami Corporation; North Charleston (SC); Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

Alcami Corporation is seeking a Sr. Process Engineer to provide technical support for drug product manufacturing. Key responsibilities include tech transfer, troubleshooting manufacturing processes, and writing validation documentation. The role requires strong communication skills and a Bachelor’s degree in a relevant field.

Ideal candidates should have over five years of experience in sterile pharmaceutical manufacturing. This is a 100% on-site position with a 1st shift schedule.

Qualifications

• 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
• Previous experience supporting tech transfer of parenteral Drug Products preferred.

Responsabilités

• Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
• Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests.
• Monitors manufacturing processes during production runs to assess technical issues and provides troubleshooting support.
• Composes process validation documentation, including CQA assessment and process validation protocols.
• Ensures compliance with cGMP and company training requirements.

Connaissances

Excellent verbal communication

Problem solving

Analytical skills

Organization

Time management

Formation

Bachelor’s degree in Engineering, Pharmacy, or Chemistry

Outils

Microsoft Office (Word, Excel, Outlook)

Description du poste

Alcami Corporation is seeking a Sr. Process Engineer to provide technical support for drug product manufacturing. Key responsibilities include tech transfer, troubleshooting manufacturing processes, and writing validation documentation. The role requires strong communication skills and a Bachelor’s degree in a relevant field.

Ideal candidates should have over five years of experience in sterile pharmaceutical manufacturing. This is a 100% on-site position with a 1st shift schedule.