Validation Engineer I - GMP Biopharma Manufacturing

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Health and Welfare Plans

Flexible work options

Job summary

Amgen’s North Carolina manufacturing site seeks a Validation Engineer I to lead development and implementation of the validation strategy, including the Validation Master Plan, equipment qualification, and cleaning validation. You will ensure GMP compliance and support regulatory filings with cross-functional teams.

Responsibilities include technical leadership in commissioning, qualification, and maintenance, plus collaboration with Manufacturing, Engineering, Quality, and Process Development

Qualifications

• 8 years of Manufacturing or Operations experience with a High School diploma
• 6 years of Manufacturing or Operations experience with an Associates degree
• 2 years of Manufacturing or Operations experience with a Bachelor's degree
• Masters degree

Responsibilities

• Provide technical support for commissioning, qualification, cleaning validation, and maintenance activities in ANC
• Collaborate with project leads on validation outputs for equipment
• Prepare and review cleaning-related documents and reports
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet validation requirements
• Support regulatory filings, audits, and inspections
• Maintain site validation master plan and monitor compliance of equipment/systems
• Lead continuous improvement initiatives in validation and process control
• Provide support to commercial/clinical manufacturing as needed
• Work with cross-functional teams to implement operational improvements
• Provide 24x7 on-call support for process systems on a rotational basis
• Conduct PQs for parts washers and autoclaves
• Create/update cleaning SOPs and work instructions

Skills

Technical writing

Project management

Cross-functional collaboration

Regulatory knowledge

Root cause analysis

Troubleshooting

Education

Masters degree

Bachelor's degree

Associates degree

High school diploma/GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen’s North Carolina manufacturing site seeks a Validation Engineer I to lead development and implementation of the validation strategy, including the Validation Master Plan, equipment qualification, and cleaning validation. You will ensure GMP compliance and support regulatory filings with cross-functional teams.

Responsibilities include technical leadership in commissioning, qualification, and maintenance, plus collaboration with Manufacturing, Engineering, Quality, and Process Development