Sr. Specialist, GxP Computer Systems

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease. 

 At Replimune, we live by our values: 

United: We Collaborate for a Common Goal. 

Audacious: We Are Bold and Innovative. 

Dedicated: We Give Our Full Commitment. 

Candid: We Are Honest With Each Other. 

People are at the center of everything we do, and when it comes to our employees, we make it personal.  With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.  

 Join us, as we reshape the future. 

 

Job Summary: 

The GxP Computer Systems Specialistr will be responsible for managing GxP-compliant and lab computer systems and ensuring their optimal performance. They will collaborate closely with various teams such as Validation, Quality, and Manufacturing to maintain the integrity of computer equipment connected to GxP systems. Their primary objective will be to ensure that these systems remain operational, audit-ready, and function within regulatory and quality guidelines, supporting the company's mission to deliver high-quality and compliant biotechnological products. This position will be located onsite in Framingham, MA, and will also need to be available to work with the UK teams remotely in the early mornings Eastern time.

      

This position is based in our Framingham location and typically has a 5-day on-site expectation. 

 

Responsibilities

Key responsibilities:

• Build, manage, configure, and monitor GxP connected and lab computer systems, particularly on Windows OS, ensuring continuous uptime, security, and performance of systems connected to laboratory and manufacturing equipment.
• Work within IT and QA Change Control systems to ensure the business is appropriately executing Change Controls on GxP and lab connected computer systems.
• Maintain administrator access on GxP software and computer systems and ensure protocol is followed in granting system access to users.
• Work closely with the Director, GxP and lab Applications and Sr. Mgr of IT Operations to create, maintain, and update all necessary GxP documentation to ensure systems are always audit-ready. Maintain SOPs, user manuals, forms, and device qualification.

• Ensure that backup and system update operations for GxP and lab computer systems are executed to specification. Monitor and verify that backup and recovery processes are functioning as required and troubleshoot issues when necessary.

• Assist the Validation, and Quality Assurance teams by assisting them in reviewing log data for potential errors, inconsistencies, or anomalies that could impact system integrity or compliance.
• Act as the primary point of contact for identifying and resolving hardware and software issues related to GxP and lab connected computer systems. Provide hands-on support for diagnostics, patching, and system upgrades.
• Work collaboratively with cross-functional teams including IT, Validation, Quality Assurance, Manufacturing, and Research & Development to support the integration and operation of GxP and lab computer systems.

 

Other responsibilities

• Ensure GxP and lab computer systems are secure and adhere to the company’s Cybersecurity strategy.
• Ensure compliance for technology projects including GDPR, Sarbanes Oxley, 201 CMR 17.00, 21 CFR Part 11and cGxP requirements.

Qualifications

Education:   

• Bachelor’s degree in Computer Science, Information Technology or equivalent experience.

  

Required Experience: 

• Must have 3-5 years experience working with GxP-compliant systems in a biotech, pharmaceutical, or medical device environment.
• Must have IT Help Desk/troubleshooting skills
• Must have lab systems support - candidates must be local for this onsite position
• Strong knowledge of GxP, 21 CFR Part 11, and GAMP5 regulations
• Experience working with audit trails, electronic record management systems and familiarity with FDA audits.
• Expertise in Windows OS administration and Microsoft’s update cycle.
• Familiarity with lab and manufacturing equipment used in biot