Alan Karner Email and Phone Number
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• 20 years of Biotechnology/Pharmaceutical engineering experience• 30 years of engineering experience• 15 years of people management experience• Strategic leader with the ability to envision, develop, and implement enterprise level programs• Ability to build cross-functional teams and maximize the skills of each member• Ability to quickly learn new processes and concepts and then achieve tangible results • Engineering lead and solution architect for several multi-million dollar complex projects
Process Design Solutions (Pds)
View- Website:
- workwithpds.com
- Employees:
- 21
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Principal ConsultantProcess Design Solutions (Pds) Dec 2016 - Present
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Director, Automation EngineeringShire Jan 2015 - Dec 2016Lexington, MaResponsible 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. -
Associate Director - EngineeringShire Mar 2008 - Jan 2015Responsible 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.
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Senior Engineering ManagerAmgen Jan 2007 - Feb 2008West 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. . -
Principal EngineerAmgen Jan 2002 - Jan 2007West 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
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Principal Consulting EngineerInvensys - Acquired By Schneider Electric Feb 1989 - Jan 2002• 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.
Alan Karner Skills
Alan Karner Education Details
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Mechanical Engineering
Frequently Asked Questions about Alan Karner
What company does Alan Karner work for?
Alan Karner works for Process Design Solutions (Pds)
What is Alan Karner's role at the current company?
Alan Karner's current role is Principal Consultant at Process Design Solutions.
What is Alan Karner's email address?
Alan Karner's email address is al****@****eda.com
What schools did Alan Karner attend?
Alan Karner attended Rensselaer Polytechnic Institute.
What skills is Alan Karner known for?
Alan Karner has skills like Biotechnology, Change Control, Gmp, U.s. Food And Drug Administration, Validation, Pharmaceutical Industry, Fda, Biopharmaceuticals, Capa, Sop, Technology Transfer, V&v.
Who are Alan Karner's colleagues?
Alan Karner's colleagues are Anna Smiechowski, Taylor Ostrum, Samantha Sargalski, Dominique O'halloran, Erinn Jambor, Paul Stanovich, Elizabeth Callahan.
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Alan Karner
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Alan Karner
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