Director, Engineering : Vaccine Expansion Project

Director, Engineering : Vaccine Expansion Project
Company:

(Confidential)


Director, Engineering : Vaccine Expansion Project

Details of the offer

Job Description Our Companys manufacturing facility in Elkton, Virginia campus is located in the Shenandoah Valley along the Shenandoah River, Blue Ridge Mountains and just a short distance from major state universities University of Virginia and James Madison University.

This position leads technical teams in the expansion of manufacturing operations in our vaccine fermentation and purification production areas. The successful candidate will be a key member of a cross functional project team tasked with rapidly increasing manufacturing capacity through capital and smaller:scale improvement projects. The position will transition to supporting operations as technical lead through production ramp up and into steady state manufacturing.

Primary Responsibilities

Directs the activities of, and administratively manages, a highly qualified salaried technical staff of 35:50 people that will qualify and demonstrate new vaccine facility systems and equipment to enable reliable and compliant manufacturing on the Elkton site
Oversees all vaccine expansion related projects on the Elkton site, by providing technical leadership, schedule integration and coordination with all functions to deliver these projects within budget and on time
Establish site strategy and execute process validation and regulatory filing
Develop organization and support structure, execute hiring and on:boarding for technical support teams
Serve as primary technical contact for Global Technical resources and sister site technical teams working on vaccine expansion
Support and contribute to development of standard work to support production requirements and RFT startup
Support and resource equipment factory and site acceptance testing, commissioning, qualification, cleaning validation, and process validation activities
The technical operations team provides tactical technical expertise to support process investigations and troubleshooting but also has strategic responsibility for improving the long term reliability and sustainability of our production processes
Provides technical support and represent the Technical Operations department during regulatory inspections and drives permanent inspection readiness as an integral part of compliance as a competitive advantage
Drives the implementation of standard work for technical resources and supports the implementation of visual management systems to enable shop floor level accountability and engagement
Education Minimum Requirement

Bachelor of Science in Engineering or Science
Required Experience and Skills

Minimum of fifteen (15) years providing technical support for pharmaceutical, vaccine, or biological manufacturing
Minimum ten (10) years of direct management experience with some experience managing other leaders
New facility design, qualification and startup for biologics and/or vaccine products
Preferred Experience and Skills

Technically proficient and has demonstrated managerial and leadership skills necessary to build and maintain a high:performance group of technical professionals
Possess a strong knowledge of business impacts and prioritization of technical initiatives
Demonstrated interpersonal skills including flexibility and ability to work in a team environment
Knowledgeable of cGMPs, financial principles, safety guidelines, engineering standards, and regulatory topics related to new facility introduction


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