Cleaning Validation & Commissioning Specialist (Pharmaceutical Manufacturing)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

Responsibilities

• Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
• Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
• Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications.
• Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
• Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified eq