Specialist, Bioprocess Engineer

Socket.dev

Millsboro (DE)

Hybrid

USD 87,000 - 137,000

Full time

3 days ago
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Job summary

Merck in the United States is seeking a BTS Specialist and manufacturing process engineer to support vaccine technology transfers and regional projects, contributing to knowledge management and continuous process improvement.

The role collaborates across Manufacturing, Quality, Regulatory Affairs, and Global Engineering Solutions to ensure compliant transfer execution, robust processes, and timely milestones; requires a bachelor’s in life sciences and 2+ years in biopharma.

Qualifications

  • 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 in a regulated (GxP) environment with strong documentation and data integrity.
  • Strong collaboration skills in cross-functional teams; ability to communicate clearly and elevate effectively.

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 action plans.
  • Support cross-functional technical workstreams/projects that enable transfer success and improve process performance.
  • Support regional knowledge management implementation by maintaining transfer packages, playbooks, lessons learned, and best practices; coordinate updates across sites.
  • Assist with post-transfer process robustness through monitoring/trending, troubleshooting, and continuous improvement in partnership with sites and Quality.
  • Contribute to training and onboarding by maintaining training materials and delivering selected modules.
  • Deliver compliant technical documentation and communication by drafting/reviewing protocols, reports, and trackers aligned with quality and regulatory expectations.

Skills

Biopharma manufacturing
Process development
Technology transfer
GxP documentation
Cross-functional collaboration
Technical problem solving
Data analysis

Education

Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy

Job description

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 elevate complex issues to senior team members as appropriate.

Key Responsibilities
  • Support vaccine technology transfersby preparing technical inputs and documentation, coordinating readiness activities, and assisting during execution and start-up at receiving sites.
  • Contribute to technical risk assessments and mitigationby gathering data, supporting fit-gap evaluations, and helping implement agreed action plans prior to transfer runs.
  • Support cross-functional technical workstreams/projectsthat enable transfer success and improve process performance, escalating risks/issues when needed.
  • Support regional knowledge management implementationfor 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 robustnessthrough monitoring/trending, troubleshooting support, and participation in investigations and continuous improvement in partnership with sites and Quality.
  • Contribute to training and onboardingby maintaining training materials and delivering selected training modules, as assigned.
  • Deliver compliant technical documentation and communicationby drafting/reviewing protocols, reports, summaries, and trackers aligned with quality, regulatory, and internal governance expectations.
Required Education
  • Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy, or related life science/engineering field.
Required Experience and Skills
  • Minimum of 2 yearsexperience in biopharmaceutical, antigen, or vaccine manufacturing, bioprocess engineering, process development, or technology transfer.
  • Working knowledge ofupstream, downstream, fill-finish and lyophilization bioprocessing operations and fundamentals ofprocess parameters definition and control strategies.
  • Experience working in aregulated (GxP) environmentwith 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 elevate effectively.
  • Continuous improvement mindset with good organizational skills and ability to manage multiple priorities.
Preferred Experience and Skills
  • Exposure toprocess characterization, scale-up/scale-down concepts, and process robustness monitoring.
  • Familiarity withUSDAregulatory 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.
Schedule Requirements
  • Able to workfirst shift, Monday through Fridayas base schedule.
  • Off-shift coverage may be requiredbased on manufacturing/transfer activities.
What We’re Looking For

We seek individuals who:

  • 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.
Why Join Us?
  • 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
Required Skills

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}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$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.

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

10/2/2026

Requisition ID

R416272

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