Senior Principal Engineer, Sterile Fill

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

The Senior Technical Expert – Aseptic Equipment & Sterile Processing serves as a global subject matter expert responsible for the design, technology selection, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment across pharmaceutical and biologics facilities. This role provides deep expertise in sterile manufacturing technologies including aseptic filling lines, isolators, barrier systems, sterilization systems, and supporting equipment. The position supports global capital projects and operational sites by ensuring equipment design and performance meet regulatory expectations, corporate engineering standards, and operational reliability requirements. The incumbent shall ensure alignment with EU GMP Annex 1 requirements, sterility assurance principles, and contamination control strategies across equipment design and operational practices. The Technical Expert also provides leadership in troubleshooting complex aseptic equipment issues, evaluating emerging technologies, and supporting successful startup and qualification of sterile manufacturing systems. As the expert in technology, this role requires leadership in adoption of best-in-class technology and engineering practices. to drive transformational performance through accelerated timelines taking advantage of digital technologies, adoption of best-in-class technologies ensuring that the design will deliver a safe, reliable, maintainable best-in-class operation. This position supports multiple strategic projects and ensuring cross-functional alignment and communication in a matrix organization with project leads along with other Operations and external functions is key to success. The incumbent will report to Director, Engineering in the Operations Transformation organization.            

Responsibilities:

• Serve as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies and provide technical leadership in the design, specification, and lifecycle management of aseptic equipment.
• Support global capital projects and manufacturing sites with expert guidance on aseptic processing technologies.
• Establish and maintain engineering standards and best practices for sterile manufacturing equipment and provide expert guidance to ensure equipment design and operational practices comply with EU GMP Annex 1: Manufacture of Sterile Medicinal Products.
• Support implementation of Contamination Control Strategies (CCS) across sterile manufacturing facilities by ensuring that equipment designs support robust sterility assurance principles including minimization of operator interventions, effective sterilization and decontamination processes
• Support contamination risk assessments and provide technical input during regulatory inspections and responses related to sterile manufacturing equipment.
• Lead technical evaluations and technology selection for aseptic manufacturing systems including Vial, syringe, and cartridge filling lines, isolators, Lyophilizers, autoclaves and sterilization systems, de-pyrogenation tunnels, CIP and SIP systems
• Conduct vendor technical assessments and due diligence.
• Support development of global equipment standards and technology roadmap and provide input to capital investment planning for sterile manufacturing technologies.
• Provide technical oversight during equipment design, procurement, and integration.
• Review vendor designs to ensure compliance with specifications and standards
• Provide technical leadership during commissioning, qualification, and startup of aseptic equipment.
• Review and approve equipment commissioning and qualification documentation including:
• FAT and SAT protocols, Commissioning plans, Installation Qualification (IQ) and Operational Qualification (OQ), support p