Laboratory GxP Systems Specialist 2

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.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary of job description:

The Laboratory GxP Systems Administrator is responsible for the administration, maintenance, compliance, and support of laboratory computerized systems used within a regulated GxP environment. The role serves as the primary liaison between laboratory users, Quality Assurance, IT, Validation, and system vendors to ensure laboratory systems remain secure, available, compliant, and maintained in a validated state.

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

Key responsibilities:

Laboratory Computerized Systems Administration

• Administer laboratory computerized systems, including user access management, system configuration, workflows, roles, permissions, reporting, and periodic access reviews.

• Maintain system inventories, asset records, software version information, backups, archives, and associated lifecycle documentation.

• Coordinate software installations, upgrades, patches, maintenance activities, and system monitoring, escalating issues and managing resolution with IT, vendors, and other stakeholders as required.

• Support system reliability, cybersecurity, data integrity, disaster recovery, and troubleshooting of laboratory applications and instrument software.

Quality and Compliance Activities

• Author, review, and support change controls, deviations, CAPAs, impact assessments, and other quality records associated with laboratory computerized systems.

• Support validation inventories, compliance assessments, audit and inspection readiness activities, and serve as a subject matter expert during internal audits and regulatory inspections.

Vendor and Project Management

• Coordinate activities performed by software vendors, consultants, and external validation contractors, including review of vendor documentation, release notes, service reports, and software lifecycle records.

• Participate in cross-functional projects involving laboratory systems and digital solutions, tracking deliverables, timelines, risks, and actions through implementation, testing, validation, and qualification activities, including FAT, SAT, commissioning, and qualification where applicable.

Training and Continuous Improvement

• Develop and deliver user training, provide guidance on compliance and data integrity requirements, and support the development and revision of SOPs, work instructions, and lifecycle management procedures.

• Drive continuous improvement initiatives related to laboratory computerized systems, system administration practices, and computer system validation processes.

Other Responsibilities

• Ensure all activities are performed in accordance with SOPs, cGMP requirements, GDocP requirements, quality standards, and safety procedures.

• Maintain personal training compliance and qualification requirements for assigned responsibilities.

• Support laboratory and quality-related investigations involving computerized systems.

• Participate in after-hours support activities when required for business continuity.

Educational Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biotechnology, Engineering, Computer Science, Information Systems, or related discipline required.

• Advanced degree or relevant professional certifications desirable.

Experience and Skill Requirements

• Minimum 5-8 years of experience administering computerized systems in a regulated GxP environment.

· Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, Windows/Active Directory environments, laboratory systems, software lifecycle, periodic review, and supplier assessment.

• Experience with change control, deviations, CAPAs, and quality management systems.

· Strong technical writing, communication, organization, stakeholder management, problem-solving, attention to detail, and ability to work independently and in cross-functional teams.

Preferred Competencies

• Experience with viewLinc, Empower, SoftMax Pro GxP, PharmSpec, BlueMountain Regulatory Asset Manager, LIMS, QuantStudio Design and Analysis software, and / or JMP software.

• Experience with Computer System Validation (CSV) and Data Integrity principles.

• Knowledge of pharmaceutical, biotechnology, or cell and gene therapy laboratory operations.

• Experience supporting cloud-hosted and SaaS-based GxP applications.

• Experience assessing and implementing software updates and cybersecurity patches within a validated environment.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.