Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Oral Solid Dose)

Merck; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Merck seeks a Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Oral Solid Dose) to lead process ownership from design through to manufacture and tech transfer at a U.S. site.

You will partner across Manufacturing, Quality, Engineering, and R&D to enable rapid tech transfers and robust commercial operations. You will drive process performance, scale-up, and continuous improvement, focusing on blending, granulation, roller compaction, tablet compression, and coating,

Qualifications

• Experience leading technology transfers for oral solid dose products.
• Experience with capital projects and CQV activities.
• Ability to drive process scale-up and validation.

Responsibilities

• Provide technical leadership for oral solid dose manufacturing processes.
• Own and coordinate CQV, startup and technology transfer activities.
• Analyze process and product data to drive improvements.
• Lead continuous improvement and debottlenecking initiatives.
• Ensure compliance with cGMP, safety and environmental standards.

Skills

Technical leadership

Process ownership

Data-driven decision-making

Troubleshooting

Cross-functional collaboration

DOE / RCA

Job description

Job Description

We have an exciting opportunity for a Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Oral Solid Dose) 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 oral solid dosage forms .

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 oral solid dose manufacturing processes , including:
  • Blending and granulation (where applicable)
  • Roller compaction (dry granulation)
  • Tablet compression
  • Film coating and finishing operations
• Act as process owner / SME for assigned unit operations, equipment, or product processes
• Provide technical input to the Capital Project Team, supporting:
  • Equipment selection and design reviews
  • Commissioning and qualification (CQV)
  • Startup readiness for OSD manufacturing lines
  • Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. process performance qualification - PPQ)
• Analyze and interpret process and product data (e.g. blend uniformity, tablet properties, coating performance) to drive data-driven decision-making and performance improvements
• Provide advanced troubleshooting support for compression, compaction, and coating issues (e.g. weight variability, hardness, sticking/picking, coating defects)

Technology Transfer & Commercialization

• Lead or play a key role in execution of technology transfers for oral solid dose products into the facility
• Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge
• Drive:
  • Process fit assessments
  • Scale-up strategy from development to commercial scale
  • Equipment capability and process comparability assessments
• Own or guide development and optimization of:
  • Master batch records (MBRs)
  • Process descriptions and control strategies
• Support integration and industrialization of new formulations and technologies (e.g. continuous manufacturing, advanced granulation approaches where applicable)

Process Optimization & Operational Excellence

• Partner with Manufacturing to ensure safe, efficient, and reliable OSD plant performance
• Identify, prioritize, and implement improvements in:
  • Content uniformity and tablet quality
  • Process robustness (e.g. compaction consistency, compression stability)
  • Yield, throughput, and cycle time
• Lead or drive continuous improvement initiatives aligned with operational excellence
• Use structured problem-solving approaches (e.g. RCA, DOE where applicable) to resolve:
  • Compression issues (e.g. capping, lamination)
  • Compaction variability
  • Coating defects (e.g. color variation, twinning, roughness)
• Monitor process trends and product quality attributes to proactively identify risks and opportunities
• Contribute to line optimization, changeover reduction, and debottlenecking activities

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 and approve batch record updates, process specifications and control strategies
• Support regulatory inspections and audits, providing technical input and ensuring inspection readiness
• Ensure high standards of data integrity and technical documentation

Cross-functional Collaboration & Influence

• Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D
• Provide clear technical direction and influence decision-making across p