Specialist, Engineering

Job Description

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’s lifesaving vaccines in bulk and finished forms.

The Process Support Lab at the Durham site is seeking a Specialist with strong technical, interpersonal, communication, and collaboration skills. The PSL Specialist will be responsible for managing key projects related to Vaccines Manufacturing support, including laboratory study execution, project planning, data analysis, technical documentation, and cross‑functional coordination. This role will support manufacturing investigations, process monitoring, technical transfer activities, and continuous improvement efforts for Durham vaccine products and pipeline programs.

The successful candidate will be a hands‑on technical contributor with familiarity in laboratory analytical equipment, cell culture processing, aseptic practices, and cGMP documentation expectations. To be successful in this role, the candidate must be able to manage multiple priorities in a fast‑paced environment while partnering effectively with Manufacturing, Quality, Technical Operations, and laboratory teams.

The candidate will be required to work in a fast‑paced environment. Off‑shift or weekend coverage will occasionally be needed to assist the technical team, based on project‑specific assignments and/or the vaccine production schedule.

• Manage key PSL projects related to Vaccines Manufacturing support, including project scope, planning, execution, documentation, and stakeholder communication.

• Serve as a technical contributor for laboratory studies supporting manufacturing investigations, process monitoring, technical transfer, and process improvement activities.

• Author and review experimental design proposals, laboratory protocols, technical reports, data summaries, and project updates in alignment with cGMP expectations.

• Apply technical understanding of vaccine manufacturing processes, including upstream processing, cell culture operations, downstream processing, drug product support, and laboratory analytics.

• Operate, coordinate, or support laboratory analytical equipment used for in-process, post-process, and investigational sample testing, including method execution, troubleshooting, and equipment readiness activities.

• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company’s existing Durham vaccine products.

• Support cell culture processing activities, including preparation, execution, monitoring, sampling, data review, and troubleshooting in laboratory or manufacturing‑support settings.

• Actively participate on cross‑functional teams to advance project goals and deliverables related to vaccine processes or analytics.

• Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations)

• Bachelor’s degree in Engineering or Science AND a minimum of two (2) years of relevant experience ORMaster’s degree in Engineering or Science ORPh.D. with relevant academic experience
• Experience in vaccine or biologics processing, including either lab‑or manufacturing‑ scale support in analytics.
• Experience authoring technical documentation within a cGMP context
• Proven technical communication (written & presentation) skills.
• Strategic plan development and management
• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

• Vaccine or biologics manufacturing within an aseptic, cGMP environment
• cGMP manufacturing or Quality Operations support including providing immediate…