Process and Equipment Engineer II

Role: Process & Equipment Engineer II supporting GMP and non-GMP utilities and equipment at Replimune's Framingham, MA manufacturing site. Responsibilities: provide engineering support for utilities (e.g., WFI, steam, gases), laboratory, and manufacturing equipment; serve as SME for equipment troubleshooting, root cause analysis, and investigation of deviations; lead projects related to equipment design, procurement, installation, and qualification; ensure compliance with cGMP, safety, and quality standards; support validation, change controls, audits, and continuous improvement initiatives. Requirements: BS in Chemical or Mechanical Engineering (Masters preferred); 5-7+ years relevant engineering experience, including 3+ years in a cGMP environment; familiarity with GMP utilities and equipment preferred; strong communication, technical writing, and interpersonal skills; ability to work independently and within teams. HighValue: GMP utilities (WFI, steam, gases), equipment ownership, equipment validation, deviation investigation, equipment projects, compliance, and safety in biologics manufacturing context. WorkSetup: onsite in Framingham, MA, typically 5 days/week; supporting equipment and utilities critical to cell/gene therapy production.