MEDVACON LIFE SCIENCES, LLC · 9 hours ago
Statistical Software Validation Engineering Consultant (JMP/ JSL/ Excel)
Boston, MA
Full-time
Hybrid
Senior Level
6+ years expMEDVACON LIFE SCIENCES, LLC is seeking a highly motivated Validation Engineer to ensure the accuracy, reliability, and compliance of statistical analysis processes for biotech clients. The role involves validating software add-ins within the JMP environment and executing protocols on-site while delivering comprehensive project reports.
ConsultingHuman ResourcesLife ScienceQuality Assurance
Responsibilities
Excel Spreadsheets: Provide Computer System Validation and Excel securing and locking down consulting services for Excel (xls) spreadsheets used in a biotech laboratory
Locking down of spreadsheets by creating “user-only” input cells, creating password protected workbook(s) and sheets, and ensuring the secure storage of excel sheets
Remote development of deliverables: including Functional Requirement Specifications (FRS), and Installation and Operational Qualifications (IOQ) Protocol
Onsite execution of the IOQ Protocol at the client facility
Onsite resolution of any deviations and nonconformances
Creation and delivery of Validation Technical Report(s) and Trace Matrices
Creation and delivery of Project Summary Report(s)
Develop and Execute Validation Protocols: Create new validation protocols and process control methods for JMP scripts, add-ins, and statistical analyses
JSL Scripting and Automation: Utilize JSL to automate data analysis workflows, generate reports, and develop internal tools and utilities
Perform Testing and Data Collection: Conduct rigorous testing and collect data to verify that JSL scripts and associated JMP functionalities comply with internal quality standards and external regulatory requirements
Documentation and Reporting: Create and maintain detailed validation reports, documentation, and error-correction procedures (SOPs) as necessary
Troubleshooting and Support: Collaborate with cross-functional teams, including Product Engineers, IT and Quality Assurance, to determine validation requirements, troubleshoot issues, and provide technical support for JMP and excel users
Unit Testing Frameworks: Implement and maintain automated unit testing scripts using the JSL unit testing framework to ensure code integrity and identify bugs during development and refinement processes
Qualification
Required
Bachelor's degree in Engineering, Statistics, Computer Science, or a relevant scientific field (e.g., Biology, Chemistry)
6+ years of experience in software validation, quality assurance, or a related field, preferably in a biotechnology, pharmaceutical and/ or laboratory environment
Fluency in Excel and JMP Scripting Language (JSL) is required, including capability for automating analyses and building user interfaces
Strong understanding of industry standards and regulations such as cGMP, cGLP, ISO, and FDA guidelines
Strong analytical and problem-solving skills
Excellent documentation and organizational skills
The ability to work both independently and as part of cross-functional teams
The ability to work in a highly complex and dynamic environment
Preferred
Experience with other scripting/programming languages is a plus
Company
MEDVACON LIFE SCIENCES, LLC
MEDVACON is a globally recognized company offering tailored FDA Quality Compliance and Technical Consulting Services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Raymond Roggero
Managing Partner
Company data provided by crunchbase