Specialist, Bioprocess Engineer

Merck; Millsboro (DE); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Merck is seeking a BTS Americas Strategic Projects Specialist and manufacturing process engineer to join the Animal Health division.

You will contribute to regional vaccine manufacturing technology transfers, working with Manufacturing, Quality, Process Development, Regulatory, and Global Engineering Solutions to ensure compliant, efficient transfer execution and stable process performance at receiving sites.

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.
• Experience in a regulated (GxP) environment with strong data integrity and documentation practices.

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 and supporting fit-gap evaluations.
• Support cross-functional technical workstreams and projects to enable transfer success and improve process performance.
• Maintain transfer packages, playbooks, lessons learned, and best practices for knowledge management across sites.
• Assist with post-transfer process robustness through monitoring, troubleshooting, and investigations in partnership with sites and Quality.
• Contribute to training and onboarding by maintaining training materials and delivering selected training modules.
• Draft/review protocols, reports, summaries, and trackers aligned with quality, regulatory, and governance expectations.

Skills

Accountability

Adaptability

Collaboration

Data Analysis

Process Improvement

Cross-Functional Collaboration

Problem Solving

Documentation

Communication

Education

Bachelor’s degree in Biotechnology / Biochemical Engineering / Chemical Engineering / Pharmacy / related life sciences

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 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/project 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.

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 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 elevate effectively.


• Continuous improvement mindset with good organizational skills and ability to manage multiple priorities.

Preferred Experience And Skills

• 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.

Schedule Requirements

• Able to work first shift, Monday through Friday as base schedule.


• Off-shift coverage may be required based 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.

Requirements

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:

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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.

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Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R416272