Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

Computer System Validation JMP (Statistical Software) Documentation Generation Process Control Project Status Reports Standard Operating Procedure Data Validation Regulatory Compliance Validation Controls Design Verification Plan And Report (DVP&R) Test Data Deviation Investigations Traceability Matrix Automated Testing Framework FDA Regulations Cross-Functional Collaboration Documentation Generation Zoom (Video Conferencing Tool)

Other Skills

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Microsoft Excel
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Quality Assurance
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Adaptability
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Analytical Skills
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Virtual Teams
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Organizational Skills
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Detail Oriented
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Problem Solving

Roles & Responsibilities

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 biotechnology, pharmaceutical and/or laboratory environments.
Fluency in Excel and JMP Scripting Language (JSL) with the ability to automate analyses and build user interfaces.
Experience with regulatory standards and guidelines such as cGMP, cGLP, ISO, and FDA.

Requirements:

Develop and execute validation protocols for JMP scripts, add-ins, and Excel-based analyses, including IOQ and process control methods.
Onsite IOQ execution at the client facility with timely resolution of deviations and nonconformances.
Lock down and validate Excel spreadsheets used in biotech workflows by creating user-only input cells, password-protected workbooks/sheets, and secure storage, and produce associated validation deliverables.
Create and deliver validation documentation (FRS, IOQ Protocols, Validation Technical Reports, Trace Matrices, Project Summary Reports) and provide troubleshooting/support for JMP and Excel users through cross-functional collaboration.

MEDVACON LIFE SCIENCES, LLC

Pharmaceuticals

About MEDVACON LIFE SCIENCES, LLC

MEDVACON is a renowned company recognized globally for providing tailored FDA Quality Compliance and Technical Consulting Services. With an unwavering commitment, MEDVACON partners with Life Sciences Companies to achieve optimal solutions while effectively managing compliance-related expenditures. MEDVACON’s extensive array of services reflects our dedication to client satisfaction. Our proficiency encompasses Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, as well as Training, Tech Transfers, and Project Management. We look forward to partnering and working with you and your organization! MEDVACON, Elevating Excellence

Company type: SME

Industry: Pharmaceuticals

Founded: 2018

Company size: 51 - 200

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Job description

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:

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

Qualifications:

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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