Replimune, Inc.

Manufacturing Process & Equipment Engineer II

Job Locations US-MA-Framingham
ID
2023-1449
Category
Engineering & Validation
Position Type
Regular Full-Time

Overview

The Process & Equipment Engineer II is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA manufacturing facility. The individual will provide routine engineering support for utilities, laboratory, and manufacturing equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities and technical expertise for a wide array of the equipment/utility portfolio serving as subject matter expert leading investigations relating to deviations in partnership with Quality, Manufacturing, and other departments.

 

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

Responsibilities

Key responsibilities:

  • Provide direct engineering support for a portion of the site utility and equipment portfolio which includes clean utilities (Pure Steam, WFI, PW, Process Gases, etc.), HVAC systems, manufacturing process equipment and miscellaneous laboratory and support equipment. Individual will serve as the key technical subject matter expert (SME) for the associated equipment.
  • Equipment ownership responsibility for the utilities, equipment and systems, which includes troubleshooting equipment to determine root cause of failure modes, owning corrective and preventative actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
  • Collaborate with cross-functional teams and/or lead investigations into equipment issues including technical writing of required quality documentation.
  • Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of construction, installation, start-up, commissioning and qualification of facilities and/or equipment.
  • Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.
  • Promote safety within the workplace by following site safety procedures, ensuring contractors are following safety requirements, performing proactive safety assessments, and fostering a safe work culture.

 

Other responsibilities

  • Support equipment and process related deviation investigations and change control activities.
  • 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 ensure utilities and equipment remain compliant with required procedures and regulations.
  • Ensure training is kept in GMP compliant state.

Qualifications

Educational requirements:

  • Minimum BS in Chemical Engineering, Mechanical Engineering or similar required, Masters in engineering preferred.

 

Experience and skill requirement:

  • A minimum of 5-7 years professional experience in engineering, facilities or operations.
  • A minimum of 3 years relevant experience in a cGMP environment is preferred.
  • Experience with GMP utilities and equipment is preferred.
  • Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are also important skills for this position.
  • Ability to work independently or in a team environment as well as being self-motivated and showing initiative.

 

Location: 

  • This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.

 

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