Senior Validation Engineer - GMP & Regulatory

Novozen Healthcare LLC; North Carolina; On-site; USD 114,000 - 128,000; Full time

Job summary

A pharmaceutical company is seeking a Validation Engineer to support GMP validation activities in a regulated manufacturing environment. The ideal candidate will have over 5 years of validation experience, particularly in compliance with FDA regulations. Responsibilities include executing lifecycle activities, performing equipment validation, and supporting regulatory inspections. This position offers a competitive salary range of $114,000 to $128,000 and is designed for a mid-senior level professional.

Qualifications

• 5+ years of validation experience in the pharmaceutical industry.
• Strong hands-on experience with GMP validation activities.
• Solid understanding of FDA regulations, including 21 CFR Parts 210, 211, and 11.

Responsibilities

• Execute and support validation lifecycle activities including URS, RA, IQ, OQ, and PQ.
• Perform equipment validation for manufacturing and packaging.
• Support computer system validation activities in accordance with 21 CFR Part 11.

Skills

GMP validation

Risk-based validation

Technical writing

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MES

LIMS

SCADA

Job description

A pharmaceutical company is seeking a Validation Engineer to support GMP validation activities in a regulated manufacturing environment. The ideal candidate will have over 5 years of validation experience, particularly in compliance with FDA regulations. Responsibilities include executing lifecycle activities, performing equipment validation, and supporting regulatory inspections. This position offers a competitive salary range of $114,000 to $128,000 and is designed for a mid-senior level professional.