Development Engineer II
SK pharmteco · Rancho Cordova, CA · 5 days ago
EngineeringFull-time
Duties And Responsibilities
- Design and execute laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.
- Develop and reconcile mass balances from laboratory through pilot scale; support commercial-scale projections.
- Evaluate process parameters and identify opportunities for optimization, yield improvement, and cycle-time reduction.
- Prepare process flow diagrams, material balances, and supporting technical documentation.
- Support pilot plant campaigns and initial manufacturing batches, including monitoring critical process parameters.
- Absorb and review batch records and scale-up documentation.
- Troubleshoot process issues during demonstration and first commercial runs.
- Collaborate with Manufacturing, Quality, and EHS to ensure safe and compliant operations.
- Identify potential safety risks related to chemical hazards, reactions, and processing steps and recommend mitigation strategies.
- Review safety data (e.g., SDS, hazard evaluations, dust hazard information) in collaboration with senior engineers.
- Support environmental and emissions documentation and ensure adherence to GMP and company safety standards.
- Support Quality by Design (QbD) initiatives, including participation in design of experiments (DoE) and evaluation of critical process parameters (CPPs).
- Analyze process data to support investigations and continuous improvement efforts.
- Contribute to technical reports and project summaries for internal and client review.
Education And Experience
- 2-5 years of relevant process development or manufacturing experience;
- Bachelor's degree in Chemical Engineering or related engineering discipline required.
Competencies/Skills
- Solid understanding of chemical engineering principles including mass and energy balances.
- Experience with laboratory and pilot-scale unit operations.
- Ability to independently analyze data and draw technical conclusions.
- Working knowledge of GMP manufacturing environments preferred.
- Strong communication and cross-functional collaboration skills.
- Proficiency in Microsoft Excel and basic data analysis tools.