Process Validation Engineer
stark pharma solutionsRaleigh (NC)
About the role
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.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this