John Doran Email and Phone Number

Facilitate the manufacture, delivery and validation of the Lighthouse Instruments Pulsar and Illuminator systems, which offer fully automated, non destructive head space inspection for finished sterile products.

• Performed project management duties for several biotechnology capital projects, ensuring stakeholder communication and project success. • Supported multiple initiatives within Merck MMD, including vaccine filling operations, Gardasil bulk vaccine production, a process development lab, a dedicated antibiotic lab and the V591 Covid-19 production facility. • Facilitated the release of automated systems for cGMP manufacturing and laboratory environments by taking each unique system through the SDLC (System Development Life Cycle). This process is used to define system requirements for configuration and qualification of regulated drug production equipment. • Participated in a CSV (Computer System Validation) COE (Community of Excellence) as the training subteam leader. In this community we helped mentor validation professionals on industry best practices related to computer system validation and meeting regulation requirements, such as those articulated in 21 CFR Part 11 and the FDA's CSA guidance. • Marketed services to develop new business leads while ensuring all deliverables are met.• Managed and trained new validation engineers to support project growth.

• Provided “on-site support” to Merck’s barrier operations department during design and execution for multiple automation equipment installation projects. • Managed subcontractor relationships from preliminary pricing to installation.• Generated project schedules while coordinating with other vendors and client needs.• Executed GMP documentation.

• Managed sub-contractor outreach and affirmative action requirements as part of our good faith effort to meet minority and women owned business coverage. • Drafted and edited pre-qualification proposals for capital construction projects. • Generated project take-offs using project drawings and specifications as provided by design engineering firm.• Assisted in multiple bid to award tunnel estimates ranging from 62 to 279 million dollars.

• Expanded GES USA’s market and customer base by increasing RFP flow within the utility-scalewind and solar market. Anticipated new contract revenues ranged from 1 to 45 million dollars.• Supported WKA business plan for launching a blade repair business in North America, whichincluded identifying blade repair material and equipment suppliers.• Drafted, negotiated and submitted quotes to customers for utility maintenance. Customers included Gamesa, Acciona, Vestas, ABB-Power One, Mitsubishi, Siemens and De Wind.

• Responsibilities included engineering tasks assigned by city engineer, Arthur Chew• Experience includes boardwalk reconstruction, flood plan management, bulkhead inspections, road design, boardwalk design, dredging permitting and design, shore protection inspections, land use planning, drainage (tidal/storm water) improvements, road rating, street grating, landscape architecture, building modifications (solar panel installation), contractor coordination, and electrical grid connection inspections.