Process Validation Engineer

Role: Process Validation Engineer

Location: Greenville, NC Onsite





Job Description:

We are seeking an experienced Process Validation Engineer to support multiple new projects, including a new aseptic fill-finish manufacturing line.





Key Responsibilities:


- Lead and execute Process Performance Qualification (PPQ) activities.
- Support technology transfer of products and processes into commercial manufacturing.
- Develop and execute process validation and revalidation strategies for Pre-Filled Syringe (PFS) operations.
- Coordinate and evaluate aseptic media fills and smoke studies.
- Support equipment qualification, AVI qualification, and aseptic processing activities.
- Perform risk assessments and author/review validation documentation.
- Support investigations related to aseptic manufacturing and process validation.
- Ensure compliance with cGMP, FDA, and global regulatory requirements.
- Collaborate with internal teams and external stakeholders throughout tech transfer, validation, and PPQ execution.






Required Skills:


- Strong Sterile Manufacturing / Fill-Finish experience
- Hands-on PPQ execution experience
- Technology Transfer experience
- Strong validation documentation and execution background
- Experience with aseptic processing, media fills, and smoke studies
- Excellent communication and stakeholder management skills