Lead CSV Validation Engineer – GMP Systems

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

FSA and HSA programs

Job summary

Genezen in Lexington, Massachusetts, is seeking a Computerized Systems Validation Lead to oversee qualification activities for GMP software applications. Responsibilities include documentation, compliance assurance, and cross-functional collaboration.

The ideal candidate should have at least 7 years of validation experience and a Bachelor’s degree in a related field. Genezen offers a competitive salary range of $115,000-$140,000 based on experience along with various benefits.

Qualifications

• 7+ years of Computer System Validation experience.
• In-depth knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP5.
• Ability to report on project activity in a clear and concise manner.

Responsibilities

• Lead Protocol generation and oversee execution for GMP software applications.
• Evaluate software validation activities to ensure compliance with FDA and ISO.
• Represent CSV during audits and inspections.

Skills

CSV experience

Communication skills

Regulatory compliance

Technical writing

Education

Bachelor’s degree in Engineering or Computer Science

Tools

Microsoft Office

Job description

Genezen in Lexington, Massachusetts, is seeking a Computerized Systems Validation Lead to oversee qualification activities for GMP software applications. Responsibilities include documentation, compliance assurance, and cross-functional collaboration.

The ideal candidate should have at least 7 years of validation experience and a Bachelor’s degree in a related field. Genezen offers a competitive salary range of $115,000-$140,000 based on experience along with various benefits.