Process Development Engineer

5Amventures; Emeryville (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

5Amventures seeks a Process Development Engineer I to join our team and advance drug-releasing microsphere processes. You will work with the Process Development team and Senior Process Engineer to validate processes, troubleshoot issues, and develop SOPs in a GMP-like QMS environment.

The role emphasizes hands-on lab work, process tech transfer support, and meticulous record keeping. Domestic/international travel to CMO sites may be required.

Qualifications

• MS or BS in Chemical, Mechanical, Manufacturing, Chemistry, Biochemistry or related field.
• For BS candidates, 2–5 years of process development and GMP experience preferred.
• Experience in CMC/pharma manufacturing or related process development is strongly preferred.
• Hands-on operation of process equipment and documentation in a GMP/QMS environment.

Responsibilities

• Oversee and validate our manufacturing process on equipment and in the lab.
• Identify process improvements and troubleshoot complex issues.
• Generate manufacturing SOPs and maintain equipment parts inventory and records.
• Collaborate with Process Development and Senior Process Engineer; support tech transfers.

Skills

Process development

GMP manufacturing

Record keeping in QMS

Data-driven analysis

CAD familiarity

Equipment operation

Automation

Education

MS or BS in relevant field

Tools

CAD

QMS systems

Job description

In this newly created role, as a Process Development Engineer I, you will work in close collaboration with our Process Development team, and our Senior Process Engineer in particular, to advance our manufacturing process technology for drug‑releasing microspheres, as we begin scale‑up to enable later phase GMP production. Key aspects of your role include oversight and hands‑on validation of our process that employs custom equipment, identifying process improvements, troubleshooting complex issues, generating manufacturing method SOPs, and maintaining a controlled inventory of equipment parts and records within our GMP‑like Quality Management System (QMS).

This role involves hands‑on process development in our lab, process technology research, and reporting and record keeping. We’re looking for an extremely organized, critical problem solver who brings experience that may include process chemistry, mechanical engineering, GMP manufacturing, process equipment maintenance, process automation, and knowledge of record keeping within a QMS.

Qualifications

• MS, or BS in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Chemistry, Biochemistry, Chemical Biology, or a similar field. For candidates with a BS, we’d like to see significant experience in process development and GMP environments (2-5 years).
• Experience in CMC (Chemistry, Manufacturing, and Controls), pharmaceutical/biopharmaceutical manufacturing, or related process development and automation is strongly preferred.
• Hands‑on experience with operation of process equipment, solid mechanical aptitude, record keeping in a QMS, aseptic processing/clean rooms, and automation.
• Process operation and development – Demonstrated ability to execute process development activities, evaluate process performance, and provide recommendations through data‑driven analysis and practical problem solving.
• Prior experience with GMP manufacturing process and managing relations with equipment providers is a huge bonus, as we expect this role to involve several collaborations with equipment providers.
• Meticulous attention to detail and record keeping. You take pride in generating clear, accurate, and traceable documentation.
• Familiarity with operating in a GMP QMS environment (batch records, deviations, CAPA, change control) is strongly preferred.
• Strong mechanical aptitude and experience in the use of tools for operation, assembly, and maintenance of development laboratory equipment and infrastructure.
• Familiarity with CAD and mechanical design would be a plus, especially when it comes to sourcing parts or working with equipment design.
• This role may require some domestic and international travel to CMO sites for on‑the‑ground tech transfer support and troubleshooting.

We believe in building balanced teams. We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.