Replimune – Abingdon-On-Thames, England, United Kingdom
Job Summary
The Maintenance Engineer is responsible for GMP and non‑GMP utilities and equipment engineering at the Milton Park facility (UK). The individual will oversee external vendors and contractors to ensure maintenance and calibration activities are performed, documented, reviewed and approved in the computerised maintenance management system (CMMS). The role also provides routine engineering support for utilities and laboratory equipment, project engineering and validation support, and carries equipment ownership responsibilities for a select portion of the equipment/utility portfolio, acting as the subject‑matter expert for investigations related to deviations in partnership with QC, QA and other departments. This position requires a five‑day on‑site presence at the Milton Park location.
Responsibilities
* Equipment ownership for utilities, facility‑owned equipment and systems—including troubleshooting, root‑cause analysis, corrective and preventive actions, change controls, preventive maintenance planning, change control assessment and continuous improvement initiatives.
* Collaborate with cross‑functional teams and/or lead investigations into equipment issues, including technical writing of required quality documentation.
* Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures.
* Review and approve vendor documentation for accuracy and compliance in the CMMS system.
* Ensure work is performed in accordance with SOPs, cGMP, safety procedures, quality standards, EH&S guidelines, regulatory agency standards and good maintenance practices.
* Promote safety within the workplace by following site safety procedures, ensuring contractors adhere to safety requirements, performing proactive safety assessments, and fostering a safe work culture.
Other Responsibilities
* Assist with internal and regulatory agency audits/inspections, serving as SME in discussions with internal and external auditors.
* Support equipment validation and maintenance activities to maintain compliance with required procedures and regulations.
* Ensure training is kept in GMP‑compliant state.
Qualifications
* Education: BSC equivalent minimum requirement in a related field or relevant work experience in a GMP environment.
* Experience: 2+ years working in a biotech/pharmaceutical environment (preferred); working knowledge of Microsoft Office; familiarity with CMMS; knowledge of cGMP documentation (facilities, QA systems, CAPAs, deviations, change controls); understanding of equipment qualification and validation requirements.
* Skills: Excellent communication and interpersonal skills, attention to detail, flexibility, technical writing, ability to work independently or in a team, self‑motivated with initiative.
About Replimune
Replimune Group, Inc. is headquartered in Woburn, MA and was founded in 2015. Our mission is to transform cancer treatment by pioneering oncolytic immunotherapies that activate a powerful, durable anti‑tumor response. For more information, visit www.replimune.com.
We are an Equal Opportunity Employer.
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