Parenteral Process Engineer: Tech Transfer & Validation

Alcami Corporation; South Carolina; On-site; USD 85,000 - 110,000; Full time

Job summary

The Process Engineer at Alcami Corporation provides technical support for clinical and commercial parenteral Drug Product manufacturing, performing tech transfers, documenting validation and batch records, troubleshooting, and coordinating lab studies in compliance with cGMP and FDA/EU requirements.

This on-site role requires a Bachelor’s degree in Engineering, Pharmacy, or Chemistry and at least 2 years of sterile manufacturing experience, with strong communication and problem-solving skills

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.

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

Education

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

Tools

Microsoft Office

Job description

The Process Engineer at Alcami Corporation provides technical support for clinical and commercial parenteral Drug Product manufacturing, performing tech transfers, documenting validation and batch records, troubleshooting, and coordinating lab studies in compliance with cGMP and FDA/EU requirements.

This on-site role requires a Bachelor’s degree in Engineering, Pharmacy, or Chemistry and at least 2 years of sterile manufacturing experience, with strong communication and problem-solving skills