Specialist, Bioprocess Engineer at Merck in USA - Delaware - De Millsboro

Job description

• For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.
• Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.
• 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.
• Demonstrate execution excellence through effective problem-solving and critical thinking.
• Embrace an entrepreneurial mindset, taking initiative and ownership of their work.
• Adapt with agility and resilience in a dynamic, fast-paced environment.
• Uphold a safety-first mindset, ensuring the well-being of themselves and their colleagues.

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.

Requirements

• Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy, or related life science/engineering field.
• 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.
• Accountability, Accountability, Adaptability, Applied Mathematics, Business Agility, Cell Culture Process Development, Collaboration, Communication, Competency Management, Construction Cost Estimating, Cross-Functional Project Management, Data Analysis, Engineering Standards, Enterprise Leadership, Entrepreneurship, Estimation and Planning, Group Dynamics, Knowledge Management, Leading Project Teams, Maintenance Supervision, Manufacturing Processes, Manufacturing Quality Control, Prioritization, Process Improvements, Product Development {+ 9 more}
• 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.
• Current Employees apply HERE
• Current Contingent Workers apply HERE

Skills

Required

• Accountability
• Adaptability
• Applied Mathematics
• Business Agility
• Cell Culture Process Development
• Collaboration
• Communication
• Competency Management
• Construction Cost Estimating
• Cross-Functional Project Management
• Data Analysis
• Engineering Standards

Preferred

• Process characterization
• Scale-up/scale-down concepts
• Process robustness monitoring
• USDA regulatory expectations
• Technical writing
• Presenting technical content
• Project team support
• Delivering to timeline milestones

Benefits

• Be part of a transformative team that will shape the future of animal health.
• Work in a region renowned for its skilled workforce, strategic location, and robust infrastructure.
• Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products.
• Help us meet a growing global demand for our portfolio of animal health solutions
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
• $87,300.00 - $137,400.00
• This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.