Purpose

AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.

The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.

Responsibilities:

• Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required
• Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management
• Provide input on risk assessments and system classifications
• Review new equipment specifications
• Manage continuous improvement projects and drive to completion
• Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols
• Work with appropriate departments and personnel to resolve validation testing issues
• Advise other departments on SOPs related to validation projects
• Maintain 100% on time training
• Achieve Site, Department and Group performance metrics
• Complete other special projects and assignments as required
• Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs