Remote Validation Engineer – CSV, IQ/OQ/PQ Expert

Initial Therapeutics, Inc.; Boston (MA); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible paid time off

Company paid holidays

Fully remote work options

Job summary

Initial Therapeutics, Inc. in Boston is hiring a Validation Engineer to create and execute validation protocols. This role includes ensuring overall quality compliance and supporting technical documentation for validation activities.

The ideal candidate will have a Bachelor’s degree in a life science field and 3-10 years of experience in the biotech industry. Strong communication skills and knowledge of FDA regulations are essential for success.

Qualifications

• 3-10 years of experience in the biotech, pharmaceutical, or medical device industry.
• Experience with FDA regulations.
• Expertise in validation protocols.

Responsibilities

• Develop and execute validation protocols.
• Support validation activities for projects.
• Write and review technical documentation.

Skills

Strong verbal and written communication skills

Knowledge of FDA cGMP, FMEA, Risk Analysis

Validation expertise in Equipment, CSV, Method, and Process

Report writing for IQ, OQ, PQ, and CSV

Education

Bachelor’s degree in a related life science field

Job description

Initial Therapeutics, Inc. in Boston is hiring a Validation Engineer to create and execute validation protocols. This role includes ensuring overall quality compliance and supporting technical documentation for validation activities.

The ideal candidate will have a Bachelor’s degree in a life science field and 3-10 years of experience in the biotech industry. Strong communication skills and knowledge of FDA regulations are essential for success.