Sr Process Engineer, Technical Ops -Drug Substance

Merck; Elkton (VA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in the United States is seeking a Senior Process Engineer, Technical Operations - Drug Substance to lead API manufacturing processes and technology transfer from development to commercial production. You will own critical unit operations, drive process scale-up, and ensure cGMP compliance within a fast-paced small-molecule manufacturing site.

Successful candidates will combine technical leadership with hands-on problem solving, partnering with R&D, QA, and Manufacturing to optimize yield,

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• 5+ years of API manufacturing, process development, or pharma operations.
• Experience in API processing, scale-up to commercial manufacturing.
• Involvement in technology transfer, validation, and process support.
• Knowledge of cGMP manufacturing and regulatory expectations.
• Troubleshooting and process optimization in manufacturing.

Responsibilities

• Provide technical leadership for API manufacturing processes, including chemical synthesis, purification, crystallization, and drying operations.
• Act as process owner/SME for assigned unit operations, equipment, or product processes.
• Lead technical input to the Capital Project Team, supporting design reviews, commissioning, qualification, and startup readiness.
• Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. pre-PPQ, PPQ).
• Analyze and interpret process data to drive data-driven decision-making and performance improvements.
• Provide advanced troubleshooting support during manufacturing campaigns, resolving complex technical issues.
• Lead or play a key role in execution of technology transfers for new products and processes into the facility.
• Partner with global R&D and network sites to ensure robust process knowledge transfer and right-first-time startup.

Skills

API processing

Scale-up

Technology transfer

cGMP

Data analysis

Education

Chemical Engineering

Job description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations - Drug Substance to join our growing team.

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you'll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

The successful candidate will provide technical leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of active pharmaceutical ingredients (APIs).

In this role, you will work as a key member of a cross-functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance.

Key Responsibilities

Technical & Process Leadership

• Provide technical leadership for API manufacturing processes, including:
  • Chemical synthesis
  • Purification and isolation
  • Crystallization and drying operations
• Act as process owner / SME for assigned unit operations, equipment, or product processes
• Lead technical input to the Capital Project Team, supporting design reviews, commissioning, qualification, and startup readiness
• Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. pre-PPQ, PPQ)
• Analyze and interpret process data to drive data-driven decision-making and performance improvements
• Provide advanced troubleshooting support during manufacturing campaigns, resolving complex technical issues

Technology Transfer & Commercialization

Lead or play a key role in execution of technology transfers for new products and processes into the facility

• Partner with global R&D and network sites to ensure robust process knowledge transfer and right-first-time startup
• Drive process fit assessments, scale-up strategy, and manufacturability evaluations
• Own or guide development and optimization of batch documentation and process instructions
• Support integration and industrialization of new technologies into manufacturing operations

Process Optimization & Operational Excellence

Partner with Manufacturing to ensure safe, efficient, and reliable plant performance

• Identify, priorities, and implement improvements in:
  • Process robustness
  • Product quality
  • Yield and throughput
• Lead or drive continuous improvement initiatives aligned with operational excellence objectives
• Use structured problem-solving approaches (e.g. RCA) to resolve deviations and recurring issues
• Monitor process performance, trends, and cycle times to proactively identify risks and opportunities
• Contribute to debottlenecking, cleaning, and turnaround optimization strategies

Compliance & Documentation

Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards

• Provide technical leadership in campaign preparation, execution, and post-campaign review
• Own or approve key batch record updates and process documentation improvements
• Support regulatory inspections and audits, providing technical input and ensuring inspection readiness
• Ensure high standards of data integrity and technical documentation quality

Cross-functional Collaboration & Influence

Act as a technical representative within cross-functional teams including Manufacturing, Quality, Engineering, Supply Chain, and R&D

• Provide clear technical direction and influence decision-making across projects and operations
• Lead or contribute to cross-functional initiatives, driving alignment and delivery of key milestones
• Support knowledge sharing and best practice transfer across the network

Qualifications:

To excel in this role, you will have:

• Degree in Chemical Engineering, Chemistry, or related discipline
• Typically 5+ years' experience in API manufacturing, process development, or pharmaceutical operations (PhD may offset experience)
• Strong experience in API processing operations and scale-up to commercial manufacturing
• Demonstrated involvement in technology transfer, validation, and process support
• Good understanding of cGMP manufacturing and regulatory expectations
• Experience in troubleshooting and process optimization in a manufacturing environment

Key Skills:

Strong analytical capability with ability to interpret complex data and drive decisions

• Demonstrated ability to lead technical workstreams or projects
• Excellent problem-solving skills with structured, science-based approach
• Effective communicator with ability to influence cross-functional stakeholders
• Proven ability to manage multiple priorities and deliver results in a dynamic environment
• Proactive, self-driven mindset with strong focus on continuous improvement and ownership

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world's most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high-performing environment.

So, if you are ready to:

• Play a key role in delivering new Drug Substance manufacturing capability
• Take ownership of processes and drive technical and operational excellence
• Develop as a technical leader in a high-impact, technology-driven environment

#ELKVACOE

Required Skills:

Adaptability, Adaptability, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Change Control Processes, Chemical Engineering, Chemical Technology, Customer-Oriented, Data-Driven Decision Making, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Environments, Manufacturing Process Validation, Operational Excellence, Pharmaceutical Biology, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Leadership, Technical Support {+ 1 more}

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

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:

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.

The salary range for this role is $117,000.00 - $184,200.00

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 .