Statistical Software Validation Engineering Consultant (JMP/ JSL/ Excel)
Remote
Full Time
Mid Level
This is a 1099 contract opportunity with no benefits.
Location: Remote and limited onsite in MetroWest Boston
Job Overview:
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.
Key Responsibilities:
Location: Remote and limited onsite in MetroWest Boston
Job Overview:
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.
Key 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
- Education: Bachelor’s degree in Engineering, Statistics, Computer Science, or a relevant scientific field (e.g., Biology, Chemistry)
- Experience: [e.g., 6+] years of experience in software validation, quality assurance, or a related field, preferably in a biotechnology, pharmaceutical and/ or laboratory environment
- Technical Skills:
- 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
- Experience with other scripting/programming languages is a plus
- Soft Skills:
- 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
Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
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