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TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process ... By submitting your resume and details, you are declaring that the information is correct and ...

Process Validation Engineer The Process Validation Engineer supports high-profile, innovative product lines from initial concept through full-scale manufacturing. This role focuses on process ...

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As of Sep 13, 2026, the average hourly pay for process validation engineer resume in the United States is $39.54, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $51.44 per hour, depending on experience, location, and employer.

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Infographic showing various Process Validation Engineer Resume job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, 3% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.

Process Validation Engineer

Concord, NC • On-site

Contractor

Re-posted 6 days ago


Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

You can also follow Stark Pharma Solutions on LinkedIn for the latest job updates:

https://www.linkedin.com/company/99455976/

Role: Process Validation Engineer

Location: North Carolina

Position Overview

We are seeking an experienced Process Validation Engineer to support multiple pharmaceutical manufacturing projects, with a primary focus on aseptic filling operations and pre-filled syringe (PFS) manufacturing. This role will be responsible for developing and executing validation strategies, supporting tech transfer initiatives, and ensuring compliant process implementation across new and existing manufacturing lines.

The ideal candidate will have strong expertise in process validation, aseptic processing, PPQ execution, media fills, smoke studies, and cGMP-regulated pharmaceutical manufacturing environments.

Key Responsibilities

  • Develop and execute process validation strategies for new and existing fill-finish manufacturing lines.
  • Lead Process Performance Qualification (PPQ) activities to demonstrate process consistency, reliability, and regulatory compliance.
  • Support revalidation activities for pre-filled syringe (PFS) filling lines and associated manufacturing processes.
  • Coordinate, execute, and evaluate aseptic media fill studies to ensure process integrity and contamination control.
  • Plan and conduct smoke studies to verify airflow patterns and aseptic processing conditions.
  • Support technology transfer projects by implementing manufacturing processes across new and existing production lines.
  • Collaborate with Manufacturing, Quality, Engineering, Validation, and external stakeholders to ensure successful project execution.
  • Participate in risk assessments, protocol development, execution, deviation management, and final reporting.
  • Support qualification activities for automated visual inspection systems and aseptic processing equipment.
  • Ensure all validation documentation complies with cGMP, FDA, and regulatory requirements.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Experience in pharmaceutical process validation within aseptic manufacturing environments.
  • Hands-on experience with:
  • Process Validation
  • Process Performance Qualification (PPQ)
  • Aseptic Media Fills
  • Smoke Studies
  • Technology Transfer
  • Experience supporting pre-filled syringe (PFS) manufacturing operations.
  • Strong understanding of cGMP regulations and validation lifecycle activities.
  • Excellent communication and cross-functional collaboration skills.