Sterile Process Validation Engineer | PPQ & Tech Transfer

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

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