Senior Specialist, Engineering, Long Term Projects

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. 

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

Durham’s Technology Transfer Senior Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs.  This is position will support the Long Term Projects team, helping bring Flash through the Milestones to get to PPQ, Licensure, and into routine production.

Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to:

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process

• Lead technical studies and author documentation associated with site commercialization efforts

• Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects

• Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)

• Collaborate with internal/external partners, e.g. Our Company sites, Procurement, Raw Material & Component Suppliers

• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

• Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

• Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

• Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements

• Provide post approval support and subject matter expertise support to ongoing manufacturing activities.

Education Minimum Requirement:

• Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.

Required Experience and Skills:

• Travel: 10% of the time

• Experience in vaccine or biologics manufacturing within a cGMP environment

• Experience authoring technical documentation within a cGMP context

• Proven leader with influence and outstanding communication (written & presentation) skills

• Experience with project strategic plan development and management

• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development

Preferred Experience and Skills:

• Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment

• Experience with technology transfer methodologies for introduction/launch of a cGMP product

• Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions

• Authored complex process change control