MEDVACON is seeking a Validation Engineer to ensure the accuracy, reliability, and compliance of a biotech client's statistical analysis processes and software add-ins developed within the JMP environment.
Requirements
- Proficient in JMP Scripting Language (JSL)
- Experienced in validation methodologies within a regulated industry framework (e.g., cGMP, FDA)
- Proficient in computer system validation of complex Excel spreadsheets
- 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
- Implement and maintain automated unit testing scripts using the JSL unit testing framework
Responsibilities
- Provide Computer System Validation and Excel securing and locking down consulting services for Excel (xls) spreadsheets used in a biotech laboratory
- 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
- 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
Other
- This is a 1099 contract opportunity with no benefits.
- Remote and limited onsite in MetroWest Boston
- The ability to work both independently and as part of cross-functional teams
- The ability to work in a highly complex and dynamic environment
- Strong analytical and problem-solving skills
