What are the responsibilities and job description for the Equipment Validation Specialist IV-UTR-AKS-25-19 position at Software Galaxy Systems, LLC?
Contract - 09 months (Possibilities of Extension)The Equipment Validation Specialist IV plays a crucial role in ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This position provides scientifically sound documented evidence to Operations, Quality Assurance, and regulatory bodies that systems and processes will perform as required, supporting a quality, compliant manufacturing environment.Job Responsibilities : Provide Subject Matter Expert support for the design, operation, and troubleshooting of equipment in Quality Control, Manufacturing, and other departments.Lead the creation and execution of validation plans for equipment changes and process improvements.Execute Installation Qualifications (IQ), Operational Qualifications (OQ), and draft Performance Qualifications (PQ) as needed.Ensure GMP equipment remains in a validated state through regular Equipment Validation activities, including maintenance quality systems review and requalification.Organize, maintain, and program validation equipment, including dataloggers and probes.Demonstrate a solid understanding of biopharmaceutical manufacturing equipment and validation procedures, including IV / IQ, SIP, Autoclaves, Clean Utilities, Temperature Mapping, and Shipping Validation.Develop validation protocols based on plans and engineering documents.Offer technical support when reviewing and approving SOPs, protocols, change controls, deviations, and CAPAs.Manage assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System.Perform other duties as assigned.Skills : Advanced technical knowledge in Quality Control and manufacturing operations.Working knowledge of Quality Systems (TrackWise) and practical applications in operations.Strong understanding of process, equipment, cleaning, and computer system validations.Ability to manage medium to large-sized projects effectively within time constraints.Demonstrates planning, organizing, and controlling competency.Strong decision-making abilities and sound problem-solving skills.Ability to collaborate cross-departmentally and with external customers.Demonstrates role-model behaviors for GMP and safety practices.Excellent written and verbal communication skills.Proficiency in MS Project, Word, Excel, PowerPoint.Education / Experience : Education : Bachelor of Science in a science-related discipline or equivalent relevant experience.Work Experience : 5-10 years in manufacturing, QC, or validation.Certifications : Preferred certifications in relevant fields (not specified).Language : Business fluent in English.
