Lead CSV Validation Engineer (GxP/GMP)

Genezen; Lexington (MA); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Choice of healthcare plans

Paid sick time

Dental & vision care

Job summary

Genezen in Lexington, Massachusetts is seeking a qualified professional to lead Computerized Systems Validation (CSV) projects. The role involves overseeing GxP systems qualification, compliance with regulatory requirements, and employing best practices to support operational excellence.

The ideal candidate will have at least 7 years of CSV experience and a relevant Bachelor's degree, with a focus on maintaining high standards in validation processes and teamwork in a fast-paced environment.

Qualifications

• 7+ years of Computer System Validation experience.
• In depth CSV experience including as a Validation lead.
• Understanding of cGMP regulations.

Responsibilities

• Lead Protocol generation, oversee execution, and approval of qualification activities.
• Review and approve qualification documentation on behalf of the validation function.
• Serve as initiator and owner of validation related change controls.

Skills

Computer System Validation

Leadership

Technical writing

Regulatory compliance

Communication skills

Education

Bachelor’s degree in Engineering, Computer Science or related discipline

Tools

Microsoft Office

Excel

Visio

Job description

Genezen in Lexington, Massachusetts is seeking a qualified professional to lead Computerized Systems Validation (CSV) projects. The role involves overseeing GxP systems qualification, compliance with regulatory requirements, and employing best practices to support operational excellence.

The ideal candidate will have at least 7 years of CSV experience and a relevant Bachelor's degree, with a focus on maintaining high standards in validation processes and teamwork in a fast-paced environment.