Bachelor's degree in engineering, Life Sciences, or related field
Experience in Process Validation in a pharmaceutical or sterile manufacturing setting
Hands-on experience with Technology Transfer and Process Performance Qualification (PPQ)
Strong knowledge of aseptic manufacturing and media fills
Experience with smoke studies and qualification activities
Excellent technical writing and communication skills
Working knowledge of FDA regulations and cGMP standards
Responsibilities
Develop and execute process validation strategies for sterile manufacturing
Lead Process Performance Qualification (PPQ) activities for PFS lines
Support technology transfer projects for seamless manufacturing implementation
Coordinate and evaluate aseptic media fill studies for compliance verification
Perform process revalidation and maintain validated processes
Support smoke studies and qualification of automated inspection systems
Collaborate with cross-functional teams during project execution
Prepare and review validation protocols, reports, and technical documentation
Benefits
Opportunities for professional development and training
Collaborative work environment across multiple disciplines
Engagement in cutting-edge pharmaceutical projects
Potential for impact through process improvements in sterile manufacturing
Supportive culture for regulatory compliance and quality assurance
Full Job Description
Job Description:
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.
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.
Requirements:
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.
