Validation Engineer II — CQV & cGMP Specialist

Replimune; Framingham (MA); On-site; USD 137,000 - 177,000; Full time

Benefits offered by this job

Performance bonus

Equity

401k match

Flexible time off

Paid holidays

Job summary

Replimune in Framingham, MA is seeking a Validation Engineer II to join the CQV team responsible for qualifying and maintaining facility equipment, utilities, instrumentation, and computerized systems in a validated state under applicable regulations.

You will collaborate with internal customers and external contractors to schedule, execute, and review qualification protocols and reports, manage CQV campaigns, and support change controls while ensuring GMP and GDP compliance.

Qualifications

• Five years of professional validation, engineering, or operations experience.
• Three years in a cGMP environment preferred.
• Experience with GMP utilities and equipment required.
• Excellent communication and interpersonal skills required.
• Attention to detail, flexibility, and technical writing skills are important.

Responsibilities

• Conduct impact and risk assessments and support user requirement specifications.
• Authors qualification, validation, and revalidation protocols and reports for facilities, equipment, and utilities.
• Ensure validation documentation complies with industry standards and regulatory requirements.
• Execute validation activities independently with limited supervision and manage risks.
• Coordinate scheduling, execution, and review of qualification/validation protocols and reports.
• Oversee vendors and contractors performing qualification activities.
• Collaborate with Engineering, Manufacturing, QA and other functions to support validation.
• Review and revise documentation to align with cGMP and GDP.
• Support change controls and deviations related to validated status.

Skills

Validation experience

Regulatory compliance

cGMP knowledge

Technical writing

Communication skills

Education

Bachelor's degree in scientific/engineering

MSc preferred

Job description

Replimune in Framingham, MA is seeking a Validation Engineer II to join the CQV team responsible for qualifying and maintaining facility equipment, utilities, instrumentation, and computerized systems in a validated state under applicable regulations.

You will collaborate with internal customers and external contractors to schedule, execute, and review qualification protocols and reports, manage CQV campaigns, and support change controls while ensuring GMP and GDP compliance.