The Senior Principal Engineer, Sterile Fill is an expert on Aseptic Equipment & Sterile Processing and provides advanced technical expertise in the design, technology selection, interface with specialist vendors, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment within pharmaceutical or biologics manufacturing facilities. This role supports capital projects and operational manufacturing sites by ensuring aseptic equipment is designed, installed, and operated in compliance with regulatory requirements, AbbVie engineering standards, and sterility assurance principles. The Sr Principal Engineer works closely with engineering, quality, PDS&T, CQV, and ME&C teams to support equipment design, generate equipment specifications and URS, determines in collaboration with key stakeholders, the performance and operational specifications of aseptic processing equipment such as filling systems, isolators, sterilization equipment, and supporting systems. The role also is responsible to ensure compliance to AbbVie standards and international regulatory requirements such as FDA and EU GMP Annex 1 requirements, contamination control strategies, and sterility assurance practices for aseptic manufacturing environments. 

Role and Responsibilities

• Provide technical expertise for aseptic manufacturing equipment design, selection, and operation.
• Support capital projects and business evaluation including equipment specification, evaluation, procurement, and installation
• Develop and review equipment specifications, technical requirements, and design documentation.
• Ensure equipment designs support sterility assurance, cleanability, maintainability, and operational efficiency and support equipment lifecycle management and technical improvements across manufacturing facilities.
• 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.
• Continue to evaluate and implement advanced technologies in aseptic manufacturing 
• equipment
• Act as the single point of expertise in aseptic equipment such as aseptic filling lines (vials, syringes, cartridges), isolators and Restricted Access Barrier Systems (RABS), Lyophilizers, Sterilization equipment (autoclaves, dry heat tunnels), CIP/SIP systems etc
• Support development of equipment standards and best practices and provide support during Commissioning & Qualification including participation in FAT, SAT, develop protocols for testing and commissioning /qualification
• Assist in  equipment installation and startup activities including resolution of technical issues during commissioning, media fill runs, demo and qualification batches
• Support PAI and regulatory inspection of the facilities
• Collaborate with operations and maintenance teams to improve equipment reliability and performance.
• Help to drive standardization of aseptic equipment platforms and engineering practices by ensuring consistency of engineering approaches across projects and sites.