Process & Equipment Engineer II - GMP Utilities SME

Replimune; Framingham (MA); On-site; USD 148,000 - 191,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune’s Process & Equipment Engineer II is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA site. The role provides routine engineering support for utilities, laboratory, and manufacturing equipment, and leads project engineering and validation activities as SME for the portfolio.

Based in Framingham, this position typically involves a 5‑day on‑site expectation and requires collaboration with Quality, Manufacturing, and other departments to

Qualifications

• Minimum BS in Chemical or Mechanical Engineering; MS preferred.
• 5–7 years in engineering, facilities or operations.
• 3+ years in a cGMP environment preferred.
• Experience with GMP utilities and equipment preferred.
• Excellent communication and technical writing skills.
• Ability to work independently or in a team.

Responsibilities

• Provide direct engineering support for site utilities and equipment; SME for associated equipment.
• Own troubleshooting, CAPA, change controls, and PM plans.
• Lead investigations with cross-functional teams and document quality records.
• Support design, procurement, installation, commissioning, and qualification of facilities/equipment.
• Ensure SOPs, cGMP, OSHA and safety standards are followed.
• Promote safety and contractor safety compliance.

Skills

Engineering experience

cGMP familiarity

Technical writing

Cross-functional collaboration

Problem solving

Education

BS in Chemical/Mechanical Eng

MS preferred

Tools

GMP equipment

Qualification/Validation

Job description

Replimune’s Process & Equipment Engineer II is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA site. The role provides routine engineering support for utilities, laboratory, and manufacturing equipment, and leads project engineering and validation activities as SME for the portfolio.

Based in Framingham, this position typically involves a 5‑day on‑site expectation and requires collaboration with Quality, Manufacturing, and other departments to