Alan Karner Email & Phone Number

Lexington, Ma

Responsible for multiple automation engineering functions supporting the operational requirements of commercial and clinical bulk drug substance manufacturing across internal Shire sites.Provided guidance and vision for the delivery of a comprehensive Automaton Strategy Model. The model provides detailed guidance on all aspects of selecting, implementing, operating, and decommissioning automation systems at Shire. The recently approved document is now being applied to three multi-million dollar projects.

Responsible for providing automation engineering and instrumentation and controls (I&C) technical support for the manufacturing of commercial and clinical bio-tech products for Shire. The group consisted of two automation managers, one I&C supervisor and a mix of full time employees and contractors. Responsible for providing engineering support for the manufacturing of commercial and clinical bio-tech products. Collaborated with Quality, Validation, Process Development, Manufacturing and Facilities groups to ensure the quality of work and provide appropriate engineering resources as required.

West Greenwich, Ri

• Responsible for the management and development of 10 engineers called Responsible System Owners (RSO’s) that provided reliable production systems and expert technical support for a large scale 24/7 bioprocess manufacturing facility. Equipment supported included a complete purification suite (Chromatography, UF/DF, and virus removal), Buffer Prep and Hold systems, Dispensing units, and Clean In Place (CIP) systems. • Responsible for the management and development of 8 RSO’s that provided support for two large scale 24/7 bioprocess manufacturing facilities. Equipment supported included 15 Media Prep and Hold systems, 35 Buffer Prep and Hold systems, 8 Dispensing units, 3 Clean In Place (CIP) systems, and 5 Equipment Prep units that have supported over 1300 bioreactor inoculations and 280 purification runs per year. .

West Greenwich, Ri

• Applied a scheduling software tool to evaluate maximum plant production capacity using current and future process models. Developed solutions to address bottlenecks. • Developed and implemented a site-wide equipment rouge inspection and maintenance program. This program reduced the amount of equipment requiring contractor passivation to three units during the last outage. • Initiated a project and provided engineering expertise to enable ARI-05 to run at a 48 hour run rate• Managed the CIP commissioning and supported the cleaning qualification of the BioNext Project (ARI-05), one of the world’s largest bioprocess manufacturing facilities• Led the development of the process wide ISA-S88.01 Batch Control Standard solution for the BioNext Project

• Overall lead engineer for three concurrent multi-million dollar biotechnology batch control projects. Assembled a team of project leads and application engineers that met or beat schedule milestones.• As one of Foxboro's leading batch control consultants, advised customers and Foxboro employees on validation and engineering methodologies that improved quality and reduced cost. These methodologies were based on FDA guidelines, cGMP, GAMP, and the ISA-S88.01 Batch Control Standard.• Control system architect for a biotechnology batch project requiring FDA validation. Established and executed validation and engineering methodologies that reduced the project effort by 50% while improving quality.