Senior Maintenance Engineer

Replimune, Inc.; Abingdon; On-site; GBP 45,000 - 65,000; Full time

Job summary

Replimune, Inc. is seeking a Senior Maintenance Engineer to oversee GMP and non-GMP utilities at their Milton Park facility. This role encompasses maintenance, vendor management, and compliance with regulatory standards and SOPs, demanding technical expertise within biotech. The successful candidate will work collaboratively across teams to enhance operational efficiency, leading investigations and ensuring compliance in all engineering activities.

Qualifications

• At least 4 years of professional experience in engineering, facilities, or operations.
• Minimum 3 years in biotech/pharmaceutical with cGMP experience.
• Knowledge of equipment qualification and validation.

Responsibilities

• Ownership of utilities and facility equipment, ensuring compliance with cGMP.
• Collaborate with teams and lead investigations into equipment issues.
• Oversee vendors and approve documentation in the CMMS system.

Skills

Troubleshooting

Change Management

Technical Writing

Attention to Detail

Interpersonal Skills

Education

BSc or equivalent in a related field

Tools

CMMS

Microsoft Office

Job description

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.

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, and a competitive total rewards program, everyone at Replimune has a unique opportunity to contribute to meaningful work that could impact patients' lives.

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). This role provides routine engineering support for utilities and laboratory equipment, as well as project engineering and validation support. It includes equipment ownership responsibilities for a portion of the equipment/utility portfolio, serving as a subject matter expert and leading investigations related to deviations in partnership with QC, QA, and other departments.

This position is based in our Milton Park location with a typical 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Ownership of utilities, facility-owned equipment, and systems, including troubleshooting, corrective and preventative actions, change controls, and continuous improvement initiatives.
• Collaborate with cross-functional teams and lead investigations into equipment issues, including technical documentation.
• Support procurement, installation, commissioning, and qualification of facilities/laboratory equipment.
• Oversee vendors and contractors to ensure compliance with cGMP policies and procedures.
• Review and approve vendor documentation in the CMMS system.
• Ensure all work complies with SOPs, cGMP, safety procedures, quality standards, EH&S guidelines, and other regulatory standards.
• Promote safety by following procedures, ensuring contractor safety compliance, and fostering a safety culture.

Other responsibilities:

• Assist with audits/inspections as SME.
• Support deviation investigations and change controls related to equipment and processes.
• Support validation and maintenance activities to ensure compliance.
• Maintain GMP-compliant training records.

Qualifications

Educational requirements:

• BSc or equivalent in a related field or GMP environment experience.

Experience and skills:

• At least 4 years of professional experience in engineering, facilities, or operations.
• Minimum 3 years in biotech/pharmaceutical with cGMP experience.
• Familiarity with CMMS for maintenance recording.
• Experience with GMP documentation, including work orders, SOPs, CAPAs, deviations, change controls.
• Knowledge of equipment qualification and validation.
• Proficiency in Microsoft Office.
• Strong communication, interpersonal, technical writing, and attention to detail skills.
• Ability to work independently and in teams, with self-motivation and initiative.