Validation Engineer - Automation Projects

Boston, MA

About the Role:

We are seeking a Validation Engineer to support automation projects within a GMP-regulated environment. You will collaborate with Engineering, APO, and Quality teams to ensure compliance with GMP and GAMP standards.

Key Responsibilities:

• Develop validation protocols for automation systems.
• Conduct system dry runs and qualification activities (in-suite and out-of-suite).
• Execute change control processes.
• Author final validation reports.

Qualifications:

• Experience: 3-5 years of validation engineering experience in a GMP environment.
• Technical Skills: Hands-on experience with automation systems (PLC/SCADA), validation methodologies, and GAMP.
• Education: Bachelor's degree in Engineering, Computer Science, or a related field.

Preferred:

• Knowledge of GMP and GAMP frameworks.
• Experience with automation upgrade projects