Sterile Process Engineer - Tech Transfer & Validation

Alcami-5; Morrisville (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Alcami is seeking a Process Engineer to provide technical support for clinical and commercial parenteral Drug Product manufacturing, including tech transfers and batch manufacturing. The role involves preparing validation documents, troubleshooting processes, and coordinating studies with the formulation development lab.

Responsibilities include CAPA investigations, master batch records, and ensuring compliance with cGMP and regulatory requirements.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field.
• Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment.
• Strong written and oral communication, documentation, and problem-solving skills.

Responsibilities

• 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, etc.
• Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Composes process validation documentation, including CQA assessment, pfMEA risk assessment, and process validation protocols.
• Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Interact with clients during routinely scheduled project meetings.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Skills

Verbal communication

Written communication

Documentation

Negotiation

Critical thinking

Analytical

Problem solving

Detail orientation

Organization

Time management

Microsoft Office

Excel

Education

Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field

Tools

Microsoft Office

Excel

Job description

Alcami is seeking a Process Engineer to provide technical support for clinical and commercial parenteral Drug Product manufacturing, including tech transfers and batch manufacturing. The role involves preparing validation documents, troubleshooting processes, and coordinating studies with the formulation development lab.

Responsibilities include CAPA investigations, master batch records, and ensuring compliance with cGMP and regulatory requirements.