Senior Validation Engineer — Lead cGMP Validation Programs

Replimune; Framingham (MA); On-site; USD 152,000 - 197,000; Full time

Benefits offered by this job

Medical insurance

401k match

Paid time off

Job summary

Replimune in Massachusetts is seeking a Senior Validation Engineer to join the validation team at the Framingham site. You will lead qualification of facilities, utilities, equipment and computerized systems, coordinating protocols, reviews and project executions to maintain a validated state.

You will manage validation campaigns, interact with internal customers and external contractors, and ensure cGMP/GDP/ALCOA compliance while guiding QA-referenced lifecycle documents and audits.

Qualifications

• A minimum of seven years in validation, engineering, or operations.
• A minimum of seven years in a cGMP environment is required.
• Experience with GMP utilities and equipment is required.
• Strong written communication and attention to detail.
• Ability to work independently or in a team with accountability.

Responsibilities

• Serve as a validation technical leader across facilities, utilities, equipment, processes, and computerized systems.
• Lead design, procurement and installation support for new equipment and facility expansion.
• Maintain validation plans and qualification/requalification documentation.
• Own and maintain validation procedures within subject matter areas.
• Develop and maintain lifecycle documents in compliance with cGMP, GDP, and ALCOA.
• Ensure systems stay in a validated state through change control and requalification.
• Investigate deviations and CAPAs and assist with troubleshooting.
• Deliver training on validation program elements to engineers.
• Keep current with regulatory changes affecting validation activities.

Skills

Validation leadership

cGMP experience

GMP utilities

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering

MSc preferred

Tools

GMP equipment

Qualification protocols

Job description

Replimune in Massachusetts is seeking a Senior Validation Engineer to join the validation team at the Framingham site. You will lead qualification of facilities, utilities, equipment and computerized systems, coordinating protocols, reviews and project executions to maintain a validated state.

You will manage validation campaigns, interact with internal customers and external contractors, and ensure cGMP/GDP/ALCOA compliance while guiding QA-referenced lifecycle documents and audits.