Process Engineer, Tech Ops – Small Molecule API

Merck; Elkton (VA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck is seeking a Process Engineer, Technical Operations - Drug Substance to support API manufacturing, technology transfer, and lifecycle improvements at a US-based facility. You will engage in design, commissioning, qualification through technology transfer, and ongoing commercial manufacture of drug substances.

The role emphasizes cross-functional collaboration, process optimization, and adherence to cGMP standards to deliver quality medicines.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline
• Typically 2-5+ years in API manufacturing, process development, or related pharmaceutical environment (PhD may offset experience)
• Exposure to API processing operations and scale-up
• Understanding of cGMP manufacturing and regulatory expectations
• Experience in process support, technology transfer, or manufacturing operations

Responsibilities

• Provide technical support for facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of APIs
• Support Capital Project Team with design, commissioning, qualification, and startup readiness
• Own assigned process equipment and manufacturing processes
• Assist in technology transfers for new products and processes into the facility
• Support development and review of batch documentation and process instructions
• Participate in cross-functional teams supporting product introduction and lifecycle management
• Monitor process performance, yields, and cycle times to identify improvement opportunities
• Contribute to operational excellence and cost-reduction initiatives

Skills

Process engineering

API manufacturing

cGMP

Scale-up

Technology transfer

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering or Chemistry

Tools

Process development software

Analytical techniques

Job description

Merck is seeking a Process Engineer, Technical Operations - Drug Substance to support API manufacturing, technology transfer, and lifecycle improvements at a US-based facility. You will engage in design, commissioning, qualification through technology transfer, and ongoing commercial manufacture of drug substances.

The role emphasizes cross-functional collaboration, process optimization, and adherence to cGMP standards to deliver quality medicines.