Senior Manager, Cleaning & Sterilization Validation

BioSpace; Holly Springs (NC); Presencial; USD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Total rewards

Career development

Inclusive culture

Resumo da oferta

Amgen in North Carolina seeks a Senior Engineer-Validation to lead the development and execution of the site validation strategy at the ANC manufacturing facility. You will supervise a team, drive cleaning/sterilization validation, qualification programs, and ensure regulatory alignment across projects and audits while advancing continuous improvement initiatives.

This role requires collaboration with Manufacturing, Quality, and Process Development, strong technical writing, and a track record

Qualificações

• Doctorate or equivalent with leadership/managerial experience.
• Experience directly managing people and leading teams, projects, or resources.
• Experience in validation/engineering for pharmaceuticals.
• Knowledge of regulatory guidelines (FDA 21 CFR Part 210/211, ICH Q7, ASTM E2500).

Responsabilidades

• Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program.
• Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities at ANC.
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment.
• Furnish technical documentation and review/approval of cleaning-related documents (e.g., characterization/inactivation reports, acceptance limits reports).

Conhecimentos

Leadership

People management

Project management

Technical writing

Validation experience

Formação académica

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Descrição da oferta de emprego

Amgen in North Carolina seeks a Senior Engineer-Validation to lead the development and execution of the site validation strategy at the ANC manufacturing facility. You will supervise a team, drive cleaning/sterilization validation, qualification programs, and ensure regulatory alignment across projects and audits while advancing continuous improvement initiatives.

This role requires collaboration with Manufacturing, Quality, and Process Development, strong technical writing, and a track record