Validation Engineer

Job Title: Validation Engineer

Location: Summit, NJ (Hybrid – 50% Onsite)

Duration: 12-Month Contract (Potential for Extension)

Job Summary:

We are seeking a Validation Engineer to support the implementation and validation of manufacturing and laboratory equipment and computerized systems. This role involves developing and executing qualification protocols, managing equipment lifecycle documentation, and ensuring compliance with FDA, cGXP, and 21 CFR Part 11 standards.

Key Responsibilities:

Author and execute validation/qualification protocols and documentation

Manage equipment/system lifecycle from procurement through validation

Interface with internal teams and vendors to support CSV and equipment qualification

Ensure compliance with regulatory standards and good documentation practices

Required Skills:

5+ years in a CSV/validation role in an FDA-regulated environment

Strong knowledge of ISPE, GAMP, 21 CFR Part 11, and cGXP

Experience with lab/manufacturing systems and equipment qualification

Excellent communication, technical writing, and multitasking skills

Proficiency in Microsoft Office (Word, Excel, Visio, Outlook)

Education:

Bachelor's degree in Engineering, Computer Science, or a related field

Work Environment:

Office and lab/manufacturing areas; may involve handling of hazardous materials following safety protocols.