Process Validation Engineer

Job Title: Process Validation Engineer

Location: GreenFiled, NC

Employment Type: W2 Only

We are seeking an experienced Process Validation Engineer to support a leading pharmaceutical client on multiple 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.

• 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.

• Process Validation

• Process Performance Qualification (PPQ)

• Tech Transfer

• Sterile Manufacturing

• Pre-Filled Syringe (PFS) Fill Lines

• Aseptic Processing & Media Fill

• Smoke Studies

• Automated Visual Inspection Qualification

• cGMP/GMP

• Excellent communication skills

Please include the following with your application:

• Updated resume

• Current location

• Work authorization

• Expected W2 hourly rate

• Two professional managerial references:

  • One from your current client/manager

  • One from your previous client/manager

  • Include Name, Title, Company, Email Address, Phone Number, and Reporting Relationship

Note:W2 candidates only.