Senior Principal Engineer, Sterile Fill

• Compensation: USD 124,500 - USD 236,500 - yearly

About Abb Vie

Abb Vie'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 in our Allergan Aesthetics portfolio.

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. The 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 ensures 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 start‑up and qualification of sterile manufacturing systems. The expert in technology requires leadership in the adoption of best‑in‑class technology and engineering practices to drive transformational performance through accelerated timelines, digital technologies and best‑in‑class designs.

This position supports multiple strategic projects and ensures cross‑functional alignment in a matrix organization with project leads along with other Operations and external functions. The incumbent reports to the Director of 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 and 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 start‑up 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 performance qualification readiness and GMP start‑up activities.
• Provide expert troubleshooting support for complex aseptic…