Entry-Level Validation Engineer – GMP & Equipment

AMERICAN REGENT, INC.; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

American Regent, Inc. in the United States seeks a Validation Engineer I to develop and execute validation protocols that support aseptic parenteral pharmaceutical manufacturing. The role ensures facilities, systems and processes stay validated and compliant with cGMP guidelines.

You will act as SME for packaging, equipment, facilities, and cleaning validation, coordinating protocol approvals and contributing to SOP development. Some travel (<10%) may be required.

Qualifications

• Bachelor’s Degree in Life Sciences, Engineering or equivalent is required.
• Minimum 1 year performing validation activities in pharmaceutical/biopharmaceutical or related Life Science industry.
• Knowledge of cGMP regulations and practices pertaining to validation principals, manufacturing processes and quality systems.

Responsibilities

• Act as SME for a designated discipline/s and support validation life cycle from design to operation.
• Develop/execute validation protocols for installation, operation and performance qualification of equipment, utilities and processes.
• Maintain lifecycle documentation including User Requirements & Functional Specifications.
• Coordinate protocol approvals and provide summary reports.
• Provide training to personnel performing validation activities.

Skills

Validation

cGMP knowledge

Communication

Project planning

Teamwork

Education

Bachelor’s Degree in Life Sciences, Engineering or equivalent

Tools

MS Office

Engineering drawings

Job description

American Regent, Inc. in the United States seeks a Validation Engineer I to develop and execute validation protocols that support aseptic parenteral pharmaceutical manufacturing. The role ensures facilities, systems and processes stay validated and compliant with cGMP guidelines.

You will act as SME for packaging, equipment, facilities, and cleaning validation, coordinating protocol approvals and contributing to SOP development. Some travel (<10%) may be required.