Computer Systems Validation Engineer

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

We are looking for a Computer Systems Validation Engineer with experience in computer systems validation work with preference to those familiar with MODA and/or LabWare interfaces. Technical duties include developing and implementing validation protocols, adhering to domestic and international GMP regulations. It also includes communicating with impact, operating collaboratively while holding themselves and other team members accountable and proactively taking steps to learn & grow based on feedback. The individual will collaborate with cross‑functional team members such as Quality Systems, Quality Control, Project management and other technical disciplines to lead execution of assigned validation deliverables of the projects.

Experience essentials

• Bachelor’s degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. Corresponding relevant experience in lieu of a bachelor's degree will be considered when assessing candidates.
• Understanding, adhering to and maintaining compliance with cGMP standards is fundamental. Position will navigate complex regulatory requirements to ensure that all changes to LIMS/MODA systems meet industry standards.
• Thorough understanding of cGXPs, GAMP5, S88 and 21CFR Part 11 (as applicable).
• In-depth knowledge of core principles of validation programs.
• Experience in Trackwise, Veeva, Kneat, ALM or other common electronic documentation systems.