Specialist, Bioprocess Engineer

MSD•Millsboro, DE

4d•$87,300 - $137,400•Hybrid

About The Position

As a BioTechnology Solutions (BTS) Specialist and manufacturing process engineer within Animal Health, this individual contributor supports vaccine manufacturing technology assessments, transfers, and associated technical activities across the Americas region. The role partners with Manufacturing, Quality, Process Development, Regulatory Affairs, Production Planning, Global Engineering Solutions, and other stakeholders to support compliant and efficient transfer execution and stable process performance at receiving sites. It contributes to regional knowledge management, technical risk assessment and mitigation, post-transfer monitoring, and continuous improvement. The Specialist may also support onboarding and training and escalates complex issues to senior team members as appropriate. The position is based in Millsboro, Delaware, with a hybrid work arrangement and a first-shift, Monday-through-Friday base schedule. Off-shift coverage may be needed based on manufacturing or transfer activities, and travel requirements are 25%.

Requirements

Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy, or a related life science or engineering field.
At least 2 years of experience in biopharmaceutical, antigen, or vaccine manufacturing, bioprocess engineering, process development, or technology transfer.
Working knowledge of upstream, downstream, fill-finish, and lyophilization bioprocessing operations and fundamentals of process parameter definition and control strategies.
Experience working in a regulated GxP environment, with strong attention to documentation and data integrity.
Ability to support technical problem-solving and investigations, and familiarity with basic risk management tools such as FMEA or similar.
Strong collaboration skills in cross-functional teams and the ability to communicate clearly and escalate effectively.
Continuous-improvement mindset, good organizational skills, and ability to manage multiple priorities.
Able to work first shift, Monday through Friday as the base schedule; off-shift coverage may be required based on manufacturing or transfer activities.

Nice To Haves

Exposure to process characterization, scale-up and scale-down concepts, and process robustness monitoring.
Familiarity with USDA regulatory expectations related to technology transfers of antigens and vaccines.
Strong technical writing skills and comfort presenting technical content to diverse stakeholders.
Experience supporting project teams and delivering against timeline milestones and critical goals in a matrixed environment.
Ability to prioritize, focus on, and obtain business results.

Responsibilities

Support vaccine technology transfers by preparing technical inputs and documentation, coordinating readiness activities, and assisting during execution and start-up at receiving sites.
Contribute to technical risk assessments and mitigation by gathering data, supporting fit-gap evaluations, and helping implement agreed action plans before transfer runs.
Support cross-functional technical workstreams and projects that enable successful transfers and improve process performance; escalate risks and issues when needed.
Maintain transfer packages, playbooks, lessons learned, and best practices for assigned processes; coordinate updates and promote consistent adoption across regional sites.
Support post-transfer process robustness through monitoring and trending, troubleshooting, investigations, and continuous improvement with sites and Quality.
Maintain training materials and deliver selected training modules as assigned.
Draft and review protocols, reports, summaries, and trackers in accordance with quality, regulatory, and internal governance expectations.