Senior CSV Validation Engineer: GMP Software Lead

Genezenlabs; 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

Healthcare plan options

Paid sick time

Job summary

Genezenlabs in Lexington, Massachusetts is seeking a Computerized Systems Validation Lead to manage CSV projects involved in gene therapy validation. The successful candidate will oversee the execution of validation activities, ensuring compliance with FDA and cGMP regulations.

Your role will involve collaborating with cross-functional teams, preparing necessary documentation, and enhancing validation programs. Expectations include strong communication skills, a bachelor's degree in a relevant field, and over 7 years of CSV experience.

Qualifications

• 7+ years of Computer System Validation experience.
• In-depth CSV experience, including as a Validation lead.
• Familiarity with 21 CFR Part 11, EU GMP Annex 11 and GAMP5.

Responsibilities

• Lead protocol generation and oversee execution of qualifications.
• Review and approve qualification documentation.
• Evaluate software validation activities for compliance.

Skills

Computer System Validation expertise

Strong communication skills

Technical writing ability

Ability to manage multiple activities

Understanding of cGMP regulations

Education

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

Tools

Microsoft Office

Excel

Visio

Job description

Genezenlabs in Lexington, Massachusetts is seeking a Computerized Systems Validation Lead to manage CSV projects involved in gene therapy validation. The successful candidate will oversee the execution of validation activities, ensuring compliance with FDA and cGMP regulations.

Your role will involve collaborating with cross-functional teams, preparing necessary documentation, and enhancing validation programs. Expectations include strong communication skills, a bachelor's degree in a relevant field, and over 7 years of CSV experience.