Process Validation Engineer

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

Job Description

We are seeking an experienced

Job Title

Process Validation Engineer

Location

GreenFiled, NC

Employment Type

W2 Only

Job Description

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.