Lead Validation Engineer, cGMP Biotech

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

Benefits offered by this job

Medical, dental & vision

401k match

Flexible time off

Year-end holidays

Job summary

Replimune Group, based in Framingham, MA, seeks a Senior Validation Engineer to qualify and maintain biotech facility equipment, utilities, instrumentation and computerized systems in a validated state.

You will coordinate with internal customers and contractors to plan, execute and review qualification protocols and reports, and manage validation campaigns through change control and requalification assessments.

Qualifications

• Seven+ years of professional experience in validation, engineering, or operations.
• Minimum seven years of relevant experience in a cGMP environment.
• Experience with GMP utilities and equipment.
• Strong attention to detail and technical writing skills.
• Ability to work independently or in a team with initiative and 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 expansions.
• Maintain validation project plans for qualification of equipment for cGMP compliance.
• Develop and maintain validation lifecycle documents and reports per cGMP, GDP, ALCOA.
• Assist with investigations of deviations and CAPAs and with audits/inspections.

Skills

Validation

cGMP experience

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor’s degree (Scientific/Engineering)

Job description

Replimune Group, based in Framingham, MA, seeks a Senior Validation Engineer to qualify and maintain biotech facility equipment, utilities, instrumentation and computerized systems in a validated state.

You will coordinate with internal customers and contractors to plan, execute and review qualification protocols and reports, and manage validation campaigns through change control and requalification assessments.