Specialist, Bioprocess Engineer

MSD Malaysia; Millsboro (DE); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision & 401(k)

Job summary

Merck & Co., Inc. is seeking a BTS Specialist and manufacturing process engineer to join the BTS Americas Strategic Projects team. You will help transfer vaccine technologies, support risk assessments, and enable robust process performance across receiving sites.

The role involves cross-functional collaboration with Quality, Regulatory Affairs, and Global Engineering Solutions, plus training and documentation duties in a GMP environment. US-based regional focus with evolving duties.

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 with data integrity in a regulated (GxP) environment.

Responsibilities

• Support vaccine technology transfers by preparing inputs and documentation and coordinating readiness at receiving sites.
• Contribute to risk assessments and mitigation by gathering data and supporting action plans.
• Support cross-functional technical workstreams and promote transfer success across sites.
• Maintain knowledge management, transfer packages, playbooks, and lessons learned across regions.
• Assist with post-transfer robustness via monitoring, troubleshooting and investigations with Quality.
• Deliver training materials and modules, and draft/ review protocols, reports and trackers.

Skills

Project management

Cross-functional collaboration

Technical writing

Process development

Quality systems

Data analysis

Documentation

Communication

Education

Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmacy, or related life science/engineering field

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/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.

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:

• 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}

Preferred Skills:

Current Employees apply HERE Current Contingent Workers apply HERE 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. Please click here if you need an accommodation during the application or hiring process. 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.

Salary and Benefits:

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.

Search Firm Representatives:

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.

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.

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.