Senior Maintenance Engineer

Atlas Venture; Woburn (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Atlas Venture is seeking a Senior Maintenance Engineer responsible for managing GMP and non-GMP utilities at their facility. The role entails equipment oversight, collaboration with vendors, compliance with safety and quality regulations, and a commitment to maintaining operational excellence in a dynamic environment.

Qualifications

• At least 4 years' experience in engineering, facilities, or operations.
• Minimum 3 years in biotech/pharmaceutical with cGMP experience.
• Familiarity with CMMS and GMP documentation practices.

Responsibilities

• Oversee utilities, facility-owned equipment, and systems.
• Collaborate with cross-functional teams on equipment issues.
• Ensure compliance with SOPs, cGMP, and safety standards.

Skills

Communication

Technical Writing

Teamwork

Initiative

Education

BSc or equivalent in a related field

Tools

Microsoft Office

Job description

About Replimune Group

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies. We imagine a world where cancer is a curable disease.

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 patients' 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 related to deviations in partnership with Quality Control (QC), Quality (QA), and other departments.

This position is based in Milton Park and typically involves a 5-day on-site work schedule.

Responsibilities

• Own responsibility for 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 for accuracy and compliance in the CMMS system.
• Ensure all work complies with SOPs, cGMP, safety, quality standards, EH&S guidelines, and regulatory requirements.
• Promote safety and a culture of safety within the workplace.

Other responsibilities include:

• Supporting audits and inspections as SME.
• Assisting with deviation investigations and change controls.
• Supporting equipment validation and maintenance activities to ensure compliance.
• Maintaining GMP-compliant training records.

Qualifications

Educational requirements:

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

Experience and skills:

• At least 4 years' experience in engineering, facilities, or operations.
• Minimum 3 years in biotech/pharmaceutical environment with cGMP experience.
• Familiarity with CMMS and GMP documentation practices.
• Knowledge of equipment qualification and validation.
• Proficiency in Microsoft Office.
• Strong communication, interpersonal, and technical writing skills.
• Ability to work independently and in teams, with initiative and motivation.