Specialist, Bioprocess Engineer

Merck • Millsboro, DE

2d • $87,300 - $137,400 • Hybrid

About The Position

As a BioTechnology Solutions (BTS) Specialist and manufacturing process engineer, you will be part of a world-class team within Animal Health, contributing directly to the production of veterinary products that improve animal health and welfare globally. The Specialist in the BTS Americas Strategic Projects team supports regional vaccine manufacturing technology assessments, transfers and associated technical activities. This individual contributor partners with Manufacturing, Quality, Process Development, Regulatory Affairs, Production Planning, Global Engineering Solutions and other stakeholders to help ensure compliant, efficient transfer execution and stable process performance at receiving sites. The role contributes to knowledge management implementation in the region, supports technical risk assessments and mitigation actions, and assists with post-transfer monitoring and continuous improvement. The Specialist may support onboarding/training activities and will escalate complex issues to senior team members as appropriate.

Requirements

• Minimum of 2 years 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 parameters definition and control strategies.
• Experience working in a regulated (GxP) environment with strong attention to documentation and data integrity.
• Demonstrated ability to support technical problem solving, investigations, and basic risk management tools (e.g., FMEA or similar).
• Strong collaboration skills in cross-functional teams; ability to communicate clearly and escalate effectively.
• Continuous improvement mindset with good organizational skills and ability to manage multiple priorities.

Nice To Haves

• Exposure to process characterization, scale-up/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 to 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 prior to transfer runs.
• Support cross-functional technical workstreams/projects that enable transfer success and improve process performance, escalating risks/issues when needed.
• Support regional knowledge management implementation for assigned processes by maintaining transfer packages, playbooks, lessons learned, and best practices; coordinate updates and promote consistent adoption across sites.
• Assist with post-transfer process robustness through monitoring/trending, troubleshooting support, and participation in investigations and continuous improvement in partnership with sites and Quality.
• Contribute to training and onboarding by maintaining training materials and delivering selected training modules, as assigned.
• Deliver compliant technical documentation and communication by drafting/reviewing protocols, reports, summaries, and trackers aligned with quality, regulatory, and internal governance expectations.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level