Tamarac, FL Job Details $75,000 - $80,000 a year 6 hours ago Qualifications Statistics New product introduction Content creation for technical audiences Quality records maintenance Production data analysis Defect resolution root cause analysis Procedural guides Technical documentation Quality control statistical data analysis Preventive action implementation Engineering Technical writing experience within manufacturing Production deviation management Production risk assessment Engineering process optimization Biotechnology Corrective and preventive actions (CAPA) GMP Metrics Reporting Mid-level ICH Q9 Data summary reports Quality reports Minitab Collaboration with product development teams Analysis skills Bachelor's degree in engineering Production validation processes HACCP Quality control documentation Full Job Description Job Summary The Process Validation Engineer I supports the design, execution, and documentation of process validation activities to ensure compliance with regulatory requirements, quality standards, and operational efficiency. This role partners with cross-functional teams to validate new and existing processes, analyze data for process capability, and drive continuous improvement within a cGMP-regulated environment. Job Responsibilities Develop, execute, and review process validation protocols (e.g., PV, PPQ) and reports. Perform risk assessments (e.g., FMEA, HACCP) to identify critical parameters and ensure process control. Analyze and interpret validation data to establish process capability and consistency using statistical tools. Author and maintain validation protocols, reports, and SOPs in compliance with FDA, EU, and ICH guidelines. Collaborate with R D, Manufacturing, Engineering, and QA/QC on technology transfer, new product introductions, and process improvements. Investigate process deviations, support CAPA implementation, and recommend corrective actions. Evaluate and implement technologies to enhance process robustness and reliability. Ensure audit readiness by maintaining complete, accurate, and compliant documentation. Support internal and external inspections by demonstrating validated processes. Provide training on validation procedures, protocols, and best practices. Prepare periodic summaries and metrics of validation activities. Perform other duties as assigned. Education Bachelor's degree in Engineering, Chemistry, Biotechnology, or a related field. Advanced degree preferred. Knowledge, Skills and Abilities Solid understanding of cGMP, FDA, EU, and ICH validation requirements (21 CFR Parts 210/211, ICH
Q8/Q9/Q10
). Proficiency with statistical analysis software (e.g., JMP, Minitab). Strong analytical, problem-solving, and technical writing skills. Effective communication, teamwork, and organizational abilities. Familiarity with manufacturing equipment, cleanroom operations, aseptic/sterile processing, and cleaning validation. Ability to manage multiple projects in a fast-paced environment. Experience 1-3 years of experience in process validation within a regulated manufacturing environment (pharmaceutical, biotechnology, or medical device industry). Hands-on experience with validation protocols, troubleshooting, and process improvements.
