Process Validation Engineer: Sterile Fill, PPQ & Tech Transfer

IT Minds LLC; Greenfield (NC); On-site; USD 96,432 - 137,760; Full time

Job summary

IT Minds LLC in Greenfield, NC is seeking an experienced Process Validation Engineer to support a leading pharmaceutical client on validation and tech transfer projects.

The ideal candidate will have hands-on experience in sterile manufacturing, process validation, PPQ execution, and pre-filled syringe (PFS) fill line operations, with a strong focus on cGMP compliance.

This is a W2 opportunity; please include an updated resume and two professional references.

Qualifications

• Hands-on experience in sterile manufacturing and process validation.
• Experience with PPQ studies and tech transfer for pharmaceutical lines.
• Familiarity with cGMP/FDA regulations and regulatory requirements.

Responsibilities

• Develop and execute process validation strategies for new fill line projects.
• Perform revalidation activities for pre-filled syringe (PFS) fill lines.
• Lead Process Performance Qualification (PPQ) studies.
• Support Tech Transfer activities for new and existing PFS manufacturing lines.
• Coordinate and evaluate aseptic media fill runs.
• Conduct smoke studies and qualification activities for automated visual inspection systems.
• Perform risk assessments and ensure compliance with cGMP, FDA, and regulatory requirements.
• Collaborate with cross-functional teams and client stakeholders throughout validation and transfer activities.

Skills

Process Validation

Process Performance Qualification

Tech Transfer

Sterile Manufacturing

Pre-Filled Syringe (PFS) Fill Lines

Aseptic Processing & Media Fill

Smoke Studies

Automated Visual Inspection Qual.

cGMP/GMP

Excellent communication skills

Job description

IT Minds LLC in Greenfield, NC is seeking an experienced Process Validation Engineer to support a leading pharmaceutical client on validation and tech transfer projects.

The ideal candidate will have hands-on experience in sterile manufacturing, process validation, PPQ execution, and pre-filled syringe (PFS) fill line operations, with a strong focus on cGMP compliance.

This is a W2 opportunity; please include an updated resume and two professional references.