Excel)

Medvacon Life Sciences-posted 16 days ago

Mid Level

Hybrid • Boston, MA

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MEDVACON is seeking a highly motivated and detail-oriented Validation Engineer to ensure the accuracy, reliability, and compliance of our biotech client’s statistical analysis processes and software add-ins developed within the JMP environment. The ideal candidate will be proficient in JMP Scripting Language (JSL) and experienced in validation methodologies within a regulated industry framework (e.g., cGMP, FDA). Individual will also need to be proficient in computer system validation of complex Excel spreadsheets, able to conduct onsite execution of IOQ protocol(s) at the client site and ensure onsite resolution of any deviations. Upon completion of the above activities, the MEDVACON Consultant will create and deliver all required project reports.

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)
Create new validation protocols and process control methods for JMP scripts, add-ins, and statistical analyses
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
Create and maintain detailed validation reports, documentation, and error-correction procedures (SOPs) as necessary
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
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

Bachelor’s degree in Engineering, Statistics, Computer Science, or a relevant scientific field (e.g., Biology, Chemistry)
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

Experience with other scripting/programming languages is a plus

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