View more categories View less categories Discipline Earth, Environment & Energy, Environmental Engineering Position Type Permanent Hours Full Time Result Type Jobs
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 Senior 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). Provide routine engineering support for utilities and laboratory equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities for a select portion of equipment/utility portfolio serving as subject matter expert leading investigations relating to deviations in partnership with Quality Control (QC), Quality (QA), and other departments.
This position is based in our Milton Park location and typically has a 5-day on-site expectation.
Responsibilities
Key responsibilities:
* Equipment ownership responsibility for utilities, facility owned equipment, and systems, including troubleshooting, corrective and preventative actions, change controls, preventative maintenance plans, and continuous improvement initiatives.
* Collaborate with cross-functional teams and lead investigations into equipment issues, including technical writing of required quality documentation.
* Provide engineering support for procurement, installation, commissioning, and qualification of facilities/laboratory equipment.
* 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 all work complies with SOPs, cGMP, safety procedures, quality standards, EH&S guidelines, other regulatory standards, and good maintenance practices.
* Promote safety within the workplace by following site safety procedures, ensuring contractors follow safety requirements, performing safety assessments, and fostering a safe work culture.
Other responsibilities:
* Assist with internal and regulatory audits/inspections, serving as SME in discussions with auditors.
* Support deviation investigations and change control activities related to equipment and processes.
* Support equipment validation and maintenance activities to ensure compliance.
* Ensure training remains in GMP compliant state.
Qualifications
Educational requirements:
* BSc equivalent minimum in a related field or work experience in GMP environment.
Experience and skill requirements:
* Minimum 4 years' professional experience in engineering, facilities, or operations.
* At least 3 years working in biotech pharmaceutical environment with cGMP experience.
* Familiarity with CMMS to record maintenance activities.
* Knowledge of facilities documentation and QA systems (CAPAs, deviations, change controls).
* Knowledge of equipment qualification and validation requirements.
* Proficiency in Microsoft Office (Word, Excel, Outlook).
* Excellent communication and interpersonal skills, attention to detail, flexibility, and technical writing skills.
* Ability to work independently or in teams, self-motivated, and proactive.
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