Validation Engineer

I am looking for an experienced Validation Engineer with extensive (10 years) cGMP Manufacturing expertise in validation of equipment and facilities to join our team. In this role you will be developing and executing validation documentation in the support of manufacturing systems. This could include manufacturing equipment, lab equipment, facilities, utilities, processes, and/or cleaning qualification and validation. The ideal candidate will have Bachelor of Science in Chemistry, Biomedical or Biotechnical or Pharmaceutical Sciences. Must have have Six Sigma Green Belt professional with a strong background in materials management, process engineering, quality assurance, and program management. This individual will have led of validated high-volume production line installations. Must be well-versed in ISO 13485, ISO 14644, ISO/TS16949, APQP, FDA GMP, and GAMP5 validation processes. Additionally, possess strong skills in Minitab analysis, lean manufacturing, value stream mapping, tooling design, and new product introduction. Key Responsibilities: Lead equipment and facilities validation efforts in compliance with ISO 13485, ISO 14644, ISO/TS16949, FDA GMP, and GAMP5. Conduct process troubleshooting and continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies. Oversee multi-site project coordination, including production line installations in international locations. Develop and review machine specifications to optimize performance and compliance. Implement value stream mapping and process optimization strategies to enhance efficiency. Perform Minitab statistical analysis for process validation and quality assurance. Serve as a trainer and auditor for FDA GMP compliance. Support new product design and introduction with a focus on regulatory compliance and manufacturability. Collaborate with cross-functional teams to ensure alignment with quality and process improvement goals. Utilize Microsoft Office Suite, including Visio and Project, for project documentation and reporting. Qualifications & Skills: Extensive experience in equipment and facilities validation in a regulated manufacturing environment. Bachelor of Science in Chemistry, Biomedical or Biotechnical or Pharmaceutical Sciences Some Six Sigma certification experience in statistical process control. Proficiency in materials management, tooling design, and process engineering. Strong experience in ISO standards (13485, 14644, TS16949), APQP, and FDA GMP compliance. Knowledge of lean manufacturing principles, value stream mapping, and process troubleshooting. Experience leading multi-site projects and working with global teams. Strong expertise in Minitab statistical analysis for validation and quality improvement. Excellent program management and mentoring skills. Fluency in English and Spanish; working knowledge of German is a plus. Immediate availability for interviews and start. Preferred Qualifications: Experience in high-volume production environments. Previous leadership in GAMP5 validation processes. Strong Microsoft Office Suite skills, including Visio and Project.