Process Validation Engineer

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Platform Hardware Validation Engineer right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Process Validation Engineer

Location: North Carolina (Onsite)

Duration: Long-Term Contract

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.

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.
  
  

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.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com