CS Validation Engineer - GMP, MODA & LabWare Expert

The Fountain Group; Lexington (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

The Fountain Group seeks a Computer Systems Validation Engineer based in Lexington, MA. The role focuses on developing and implementing validation protocols to comply with domestic and international GMP regulations, with the added preference for those experienced with MODA and LabWare interfaces.

Ideal candidates will possess at least 5 years of experience in the pharmaceutical or biopharmaceutical industry, a Bachelor’s degree in a technical field, and a strong understanding of core validation program principles.

Qualifications

• A minimum of 5 years in pharmaceutical and/or biopharmaceutical industry experience.
• Thorough understanding of cGXPs, GAMP5, and 21CFR Part 11.
• Strong communication skills and accountability.

Responsibilities

• Develop and implement validation protocols.
• Navigate complex regulatory requirements.
• Lead execution of assigned validation deliverables.

Skills

Computer systems validation

Understanding of cGMP standards

Experience with electronic documentation systems

Cross-functional collaboration

Education

Bachelor’s degree in a technical discipline

Tools

Trackwise

Veeva

Kneat

ALM

Job description

The Fountain Group seeks a Computer Systems Validation Engineer based in Lexington, MA. The role focuses on developing and implementing validation protocols to comply with domestic and international GMP regulations, with the added preference for those experienced with MODA and LabWare interfaces.

Ideal candidates will possess at least 5 years of experience in the pharmaceutical or biopharmaceutical industry, a Bachelor’s degree in a technical field, and a strong understanding of core validation program principles.