Validation Engineer

Katalyst-Healthcares-; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Katalyst-Healthcares- in Boston is seeking a Validation Engineer to support the development and execution of validation protocols across processes, equipment, utilities, and systems, ensuring compliance with cGMP and regulatory standards.

You will generate lifecycle documentation (FAT, SAT, IOQ, PQ), write and revise validation protocols and master plans, and assist with regulatory observations and requalification activities to keep facilities compliant and validated.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 2–5 years of validation/engineering experience in biotech, pharma, or medical device industry.
• Knowledge of FDA cGMP, FMEA, and Risk Analysis.
• Experience with process equipment, utilities, clean room, and/or computer systems validation.
• Strong technical writing and communication skills.

Responsibilities

• Generate and execute lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, facilities, and processes.
• Write, review, and revise validation protocols, SOPs, master plans, and technical documents.
• Support validation activities including execution, review, and closure of lifecycle documents.
• Perform P&ID walkdowns, drawing reviews, ETOP verification, and thermal mapping of chambers.
• Assist with regulatory observations, periodic reviews, and requalification activities.

Skills

Validation experience

Technical writing

Regulatory knowledge

Communication skills

Education

Bachelor's degree in Life Sciences/Engineering

Job description

We are Seeking a Validation Engineer to support the development and execution of validation protocols across processes, equipment, utilities, and systems, ensuring compliance with cGMP and regulatory standards.

Roles & Responsibilities:

• Generate and execute lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, facilities, and processes
• Write, review, and revise validation protocols, SOPs, master plans, and technical documents
• Support validation activities including execution, review, and closure of lifecycle documents
• Perform Pamp;ID walkdowns, drawing reviews, ETOP verification, and thermal mapping of chambers
• Assist with regulatory observations, periodic reviews, and requalification activities

Education & Experience :

• Bachelor's degree in Life Sciences, Engineering, or related discipline
• 2–5yrs of validation/engineering experience in biotech, pharma, or medical device industry
• Knowledge of FDA cGMP, FMEA, and Risk Analysis
• Experience with process equipment, utilities, clean room, and/or computer systems validation
• Strong technical writing and communication skills