Process Validation Engineer

Stark Pharma Solutions Inc; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. in North Carolina is seeking an experienced Process Validation Engineer to support sterile GMP manufacturing projects. You will lead PPQ activities for pre-filled syringe lines, coordinate technology transfer, and ensure cGMP and FDA regulatory compliance across projects.

Collaborative work with Manufacturing, Quality, Validation, and Engineering is essential to success. Strong writing and cross‑functional teamwork are essential to deliver robust, compliant processes

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related discipline.
• Experience in Process Validation within pharmaceutical or sterile manufacturing.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing and media fills.
• Experience supporting smoke studies and qualification activities.
• Excellent technical writing and cross-functional collaboration skills.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle.

Responsibilities

• Develop and execute process validation strategies for new and existing sterile processes.
• Lead PPQ activities for PFS fill lines.
• Support technology transfer projects across production lines.
• Coordinate aseptic media fill studies to verify process performance.
• Perform process revalidation and maintain validated processes.
• Support smoke studies and qualification activities for automated inspection.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and partners.
• Prepare and review validation protocols, reports, risk assessments, and docs.
• Ensure compliance with cGMP and FDA regulations.
• Provide technical support for investigations and continuous improvement.

Skills

Process Validation

Aseptic Processing

PPQ Execution

Technology Transfer

Cross-functional Collaboration

Regulatory Compliance

cGMP Knowledge

FDA Regulations

Technical Writing

Quality Assurance

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Job description

Job Overview

We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.

Position: Process Validation Engineer

Location

North Carolina (Onsite)

Duration

Long-Term Contract

Key Responsibilities

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
• Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Perform process revalidation activities and maintain validated manufacturing processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
• Experience supporting smoke studies and qualification activities.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.