Process Validation Engineer

About the Role

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.

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.

Required Skills

• 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

Candidate Submission Requirements

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.