Specialist, Engineering

Role: Technology Operations Specialist supporting vaccine manufacturing at Merck's Durham, NC facility. Primary objectives include implementing process technologies, supporting post-approval manufacturing, and enhancing commercial vaccine processes in Drug Substance and Media areas. Responsibilities encompass providing technical leadership for technology transfer, process validation, investigations, and regulatory document preparation; managing change controls; and supporting regulatory inspections. The role requires deep subject matter expertise in biologics or vaccine manufacturing, especially in cGMP environments, with a focus on upstream/downstream processes, media development, and process validation. Qualifications include a Bachelor's in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field, with at least 2 years of relevant experience; advanced degrees preferred. Experience in vaccine or biologics manufacturing, process technology transfer, deviation investigations, validation, and regulatory interactions is essential, with preferred skills in SAP, MES, Delta V, and process risk assessments. The position involves cross-functional collaboration within manufacturing, quality, and regulatory teams, with 10% travel. The work setup may require off-shift and weekend coverage based on operational needs.