Validation Engineer I — Lead GMP Validation & Equipment

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement & Savings Plan

Group medical/dental/vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen NC manufacturing is seeking a Validation Engineer I to lead validation strategy and documentation, driving qualification activities for equipment and processes. You will collaborate with Manufacturing, Engineering, QA, and Process Development to ensure compliant execution.

The role requires strong technical writing, project management, and hands-on validation expertise, including autoclave and cleaning validation, with on-call support as needed.

Qualifications

• Experience developing validation strategies and documentation to meet regulatory requirements.
• Strong writing and presentation skills for technical and senior management reviews.
• Ability to work with cross-functional teams and manage multiple priorities.

Responsibilities

• Lead development and implementation of the Validation Master Plan and related plans.
• Generate and review validation documents, reports, and SOPs for regulatory filings.
• Coordinate with Manufacturing, Engineering, QA, and Process Development to meet validation needs.
• Support audits and inspections, and maintain the site validation master plan.
• Provide on-call support and drive continuous improvement in validation processes.

Skills

Validation strategy

Documentation & SOP writing

Cross-functional collaboration

Root cause analysis

Education

High school diploma / GED

Associates degree

Bachelor's degree

Master's degree

Tools

Kneat

CDOCs

Laboratory Inventory Management System

PI database

Job description

Amgen NC manufacturing is seeking a Validation Engineer I to lead validation strategy and documentation, driving qualification activities for equipment and processes. You will collaborate with Manufacturing, Engineering, QA, and Process Development to ensure compliant execution.

The role requires strong technical writing, project management, and hands-on validation expertise, including autoclave and cleaning validation, with on-call support as needed.