Validation Engineer

Ameri-partners; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Ameri Partners is seeking a Validation Engineer to support equipment, utilities, facilities, processes, and systems in a regulated life sciences environment. The role involves collaborating with Quality, Engineering, and Manufacturing to ensure cGMP compliance and successful qualification activities.

You will develop and execute FAT, SAT, IOQ, and PQ protocols, perform P&ID walkdowns, and contribute to risk assessments and discrepancy resolution.

Qualifications

• Bachelor's degree required in Engineering, Life Sciences, or related field.
• 3–4 years of validation or engineering experience in pharma, biotech, or medical devices.
• Working knowledge of FDA cGMP, FMEA, and risk assessment.
• Strong technical writing and communication skills.

Responsibilities

• Develop, review, and execute FAT, SAT, IOQ, and PQ protocols and reports.
• Perform P&ID walkdowns, drawing reviews, ETOP verification, and thermal mapping.
• Support risk assessments, discrepancy resolution, requalification, and periodic reviews.
• Collaborate with Quality, Engineering, and Manufacturing to maintain cGMP compliance.

Skills

FMEA

Risk assessment

cGMP

Technical writing

Communication

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Ameri Partners is seeking a Validation Engineer to support equipment, utilities, facilities, processes, and systems in a regulated life sciences environment.

Responsibilities

• Develop, review, and execute FAT, SAT, IOQ, and PQ protocols and reports.
• Perform P&ID walkdowns, drawing reviews, ETOP verification, and thermal mapping.
• Support risk assessments, discrepancy resolution, requalification, and periodic reviews.
• Collaborate with Quality, Engineering, and Manufacturing to maintain cGMP compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3–4 years of validation or engineering experience in pharma, biotech, or medical devices.
• Working knowledge of FDA cGMP, FMEA, and risk assessment.
• Strong technical writing and communication skills.