Associate Process Engineer: Tech Ops for API Transfer

Biopharma Careers; Elkton (KY); On-site; USD 72,000 - 113,000; Full time

Job summary

Biopharma Careers is seeking an Assoc. Process Engineer, Technical Operations – Drug Substance for our US-based manufacturing site.

You will support API processing, qualification, tech transfer, and commercial manufacture with a focus on quality, safety, and operational excellence. The role requires a Chemistry/Process Engineering background and 1–4+ years in API manufacturing or related pharma environment, with strong data analysis and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in Chemical or Process Engineering or related discipline.
• 1–4+ years’ experience in API manufacturing, process development, or related pharmaceutical environment.
• Exposure to API processing operations and scale-up.
• Understanding of cGMP manufacturing and regulatory expectations.
• Experience in technology transfer and 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 and startup readiness.
• Maintain on-the-floor technical support during manufacturing campaigns and troubleshooting.
• Contribute to technology transfer for new products and processes into the facility.
• Support batch documentation and process instructions and manage process improvements.

Skills

API processing

Process development

Scale-up

Data analysis

Cross-functional collaboration

Regulatory knowledge

Problem solving

Education

Bachelor's degree in Chemical or Process Engineering

Job description

Biopharma Careers is seeking an Assoc. Process Engineer, Technical Operations – Drug Substance for our US-based manufacturing site.

You will support API processing, qualification, tech transfer, and commercial manufacture with a focus on quality, safety, and operational excellence. The role requires a Chemistry/Process Engineering background and 1–4+ years in API manufacturing or related pharma environment, with strong data analysis and cross-functional collaboration skills.