Grantek

Industry 4.0 Consultant

• Focused on delivering exceptional results, valuable insights, and guidance to Grantek's life sciences customers.

Director, Consulting - Life Sciences

• Responsible for delivering outcomes through a portfolio of solutions and programs created and managed via a product management approach, providing greater value to our clients.

Director, Smart Manufacturing Solutions

• Leads Grantek's life sciences practice, providing governance and ensuring successful execution both for Grantek and our pharmaceutical, biopharmaceutical and medical devices customers
• Responsible for translating current trends in the life sciences industry landscape into actionable technical partnership opportunities, training plans, and growth strategies for the Grantek team

Director, Life Sciences

• Responsible for the growth and development of a team of 20 highly skilled automation, MES and software engineers, focused on delivering highly innovative solutions within the life sciences industry
• As a Senior Manager, provided guidance to 3 Associate Engineering Managers as they grew and developed their own teams
• Developed and marketed a Data Integrity consultation practice, and rolled it out to the Engineering and Consulting teams for implementation across multiple clients throughout North America

Senior Engineering Manager, Systems Group

• Responsible for the growth and development of a team of 15 highly skilled automation, MES and software engineers, focused on delivering highly innovative solutions within the life sciences industry
• Developed a life sciences-focused internal training program for new hires.  Topics include cGMPs, ISPE GAMP, 21 CFR Part 11, and ISA-88 for pharmaceutical processes
• Performed as the "Acting Director of Automation" for a biopharmaceutical CDMO.  Responsibilities included:
- Review of automation solutions to identify and evaluate regulatory gaps and business risks
- Identifying internal projects, prioritizing according to regulatory and business risk, and developing implementation plans accordingly
- Creation, review, and maintenance of Standard Operating Procedures and Work Instructions for the Engineering Department, focused specifically on automation
- Collaborated with Quality, Validation, and Production to determine staffing, training, and professional development paths for engineering personnel

Engineering Manager, Systems Group

• Managed the design, integration, commissioning and qualification of multiple large-scale ($1M+) process and packaging automation projects at many pharmaceutical and biopharmaceutical facilities across North America
• Responsible for the professional development and career growth of a team of highly skilled automation and software engineers (6 direct reports)

Manager, Systems

Selected Projects:
• Project manager for the automation of a blood plasma fractionation and purification process system based on ANSI/ISA-88 standards; managed the integration of cryoprecipitate dissolution, chromatography, nano-filtration, tangential flow filtration, clean utilities, CIP, and buffer preparation systems into an existing CMO facility
• Project manager for a platform retrofit of a raw material/work-in-progress yield management system at an oral solid dose facility; duties included project costing, management of development & testing activities, training of operators, and validation support
• Lead automation consultant for the design of a new vaccine manufacturing facility; duties included managing the project budget and timeline, tracking deliverable milestones, GAMP documentation development & review for process equipment, and providing direction for vendor design & qualification documentation

Systems Engineer

Selected Projects:
• Owner's representative for the procurement, commissioning and qualification of logistics and material handling equipment for a site expansion at an oral solid dose facility; duties included training and monitoring of software and electrical designers on-site in Italy, development of GAMP documentation, and supervising FAT testing
• Led acceptance testing activities for an automated warehouse management system at an oral solid dose facility; duties included development and execution of acceptance testing protocols, tracking project progress to an extremely tight timeline, and tracking deliverables with software designers
• Designed, commissioned and tested PLC/SCADA-based control systems for automated powder feed systems at an oral solid dose facility; implemented RFID tracking and ERP integration within the systems; supported the computer system validation activities to qualify the equipment
• Designed, commissioned and tested an automated warehouse management system for a liquid dose pharmaceutical facility, including PLC and SCADA development

Systems Designer

Life Sciences Professional | Helping Manufacturers Achieve Operational Excellence Through the Innovative Use of Technology

I'm passionate about technology and strive to use it for the benefit of others, which is why I focus my energy on the life sciences industry.  I take pride in the fact that the technical solutions Grantek implements are helping those companies that manufacture life saving and beneficial medicines and therapeutic products.

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