Computer Validation Analyst

Are you a Computer Systems Validation Engineer with Chromatography experience?

We have a long-term contract in the Cambridge, MA area.

Candidates MUST BE LOCATED within commutable distance as this is a fully onsite position.

NO C2C Assistance PLEASE. This is a direct/W2 project. IF you are a C2C company, please do not call/email for this requirement.

Chromatography Data Systems preferably with both Empower and Chromeleon as the primary requirement.

Senior Computer Validation Analyst / Application Operations Engineer – Chromatography Data Systems (CDS)

Location:
Cambridge MA

Time zones Supported:
Pacific, Central, Eastern

Join Milestone's Chromatography Data Systems (CDS) Product Team as a Sr. Associate IS Analyst / Sr. Application Operations Engineer, playing a pivotal role in supporting, modernizing, and optimizing our lab informatics ecosystem. You will collaborate closely with lab scientists, engineers, IT teams, and business stakeholders to deploy, integrate, and maintain CDS platforms including Empower, Chromeleon, and Unicorn, ensuring reliable instrument connectivity, data flow, system resiliency, and regulatory compliance. Your expertise will support software lifecycle activities, GxP validation, test execution, change control, and documentation aligned with industry regulations like GAMP 5 and 21 CFR Part 11.

Further, you will contribute to data integration initiatives, translating CDS-derived data into enterprise data fabrics to accelerate analytics and AI-readiness, applying machine learning and Gen AI techniques to improve operational workflows. This role suits a technically skilled professional with strong experience in life sciences IT, software support and validation, data engineering, and a passion for digital transformation.

Key Responsibilities

• Support installation, configuration, patching, upgrades, validation, and ongoing maintenance of CDS platforms (Empower, Chromeleon, Unicorn).
• Actively participate in software development lifecycles, including design discussions, testing, compliance audits, and documentation, following SAFe Agile methodologies.
• Manage software, hardware, and firmware lifecycle for CDS applications, ensuring adherence to ITIL and quality standards.
• Collaborate with lab scientists and instrument owners to ensure seamless instrument provisioning, controller support, and data acquisition.
• Perform troubleshooting of software, hardware, and network issues within laboratory IT environments.
• Lead projects or work collaboratively to drive platform innovation and sustain operational business goals.
• Develop and maintain validation documentation: IQ/OQ protocols, test scripts, user requirement specifications, and SOP updates related to change control management.
• Maintain backup and disaster recovery plans for CDS applications.
• Support compliance with quality and GxP regulations, including managing vulnerability remediation and validation of computer systems.
• Monitor and evaluate emerging technologies to enhance CDS platform capabilities and performance.
• Apply data engineering and AI/ML techniques to leverage CDS data for improved insights and process optimization.
• Provide strong customer service and effective communication to support global and virtual teams.

Required Qualifications & Skills

Education & Experience:

• Doctorate with 2+ years, or Master's with 8-10 years, or Bachelor's with 10-14 years, or Diploma with 14-18 years in Engineering, IT, Computer Science, Information Systems, Life Sciences, or related fields.
• Minimum 8-9 years in the pharmaceutical, biotech, or related life sciences industry with experience supporting GxP-regulated systems.

Technical Skills:

• Extensive experience with Chromatography Data Systems: Empower, Chromeleon, Unicorn.
• Proficiency in .Net, C#, or similar tech stacks.
• Experience in software development lifecycles, patching, validation, testing, and documentation.
• Understanding of GAMP 5, 21 CFR Part 11, 210, and 211 compliance and validation processes for computer systems.
• Familiarity with ITIL, SAFe Agile Framework, SDLC, and change control management.
• Strong Microsoft Office skills (Excel, PowerPoint, Visio, Project), and tools such as Smartsheet, ServiceNow.
• Knowledge of data engineering platforms (e.g., Databricks) and scripting languages (Python) preferred.

Preferred / Good-to-Have Skills

• Experience in biopharmaceuticals or biotechnology environments.
• Hands-on experience developing and executing GxP validation test protocols.
• Ability to develop IQ/OQ scripts, user requirement specifications, functional and design documentation.
• Experience driving digital transformation initiatives and applying AI/ML to lab data workflows.
• Strong organizational skills and ability to prioritize multiple tasks in a fast-paced, cross-functional environment.

Soft Skills

• Detail-oriented with strong analytical, problem-solving, and troubleshooting capabilities.
• Excellent communication (verbal and written), collaboration, and customer service skills.
• Self-motivated, eager to learn emerging technologies and adapt to changing project demands.
• Ability to work effectively with remote, global, and virtual teams.

This role provides an exciting opportunity to combine deep lab informatics expertise with software engineering and data science techniques, contributing to Milestone's mission to serve every patient every time through innovation in life sciences digital ecosystems.