Manufacturing Sciences & Technology (MSAT) Process Engineer, 3rd Shift
Description For Manufacturing Sciences & Technology (MSAT) Process Engineer, 3rd Shift
Orca Bio is a late-stage biotechnology company focused on redefining the transplant process through next-generation cell therapies. They aim to provide better survival rates with fewer risks for blood cancer patients. The MSAT Process Engineer role is crucial in improving the efficiency and safety of drug product manufacturing. Working on the 3rd shift (Monday-Thursday, 4x10s), this position involves process monitoring, troubleshooting, implementing improvements, and supporting investigations. Key responsibilities include generating metrics, supporting process changes, investigating events, performing root cause analysis, and managing validation protocols. The ideal candidate should have a B.S. in Engineering or similar fields, 3+ years of experience in manufacturing processes, and strong problem-solving skills. This role offers an opportunity to work in a fast-paced startup environment while contributing to potentially life-changing medical advancements. The company culture emphasizes passion, courage, integrity, and innovation, with a focus on improving patients' quality of life.
Responsibilities For Manufacturing Sciences & Technology (MSAT) Process Engineer, 3rd Shift
- Performs ongoing monitoring of existing commercial products and processes
- Generate metrics and reports for process monitoring and continuous process verification
- Support process improvements and changes including electronic batch record creation and modifications
- Investigates process events and implements corrective and preventive actions
- Provides troubleshooting support for manufacturing events, equipment performance and material issues
- Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
- Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
- Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities
Requirements For Manufacturing Sciences & Technology (MSAT) Process Engineer, 3rd Shift
- B.S. in Engineering or similar fields
- 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
- Prior experience in regulated, GMP manufacturing operations
- Experience in biotechnology and cell therapy manufacturing preferred
- Strong communication and problem solving skills
- Highly detail oriented with special attention to quality, compliance and safety
- Ability to multitask and handle multiple responsibilities simultaneously
- Strong interpersonal skills
- Ability to work in a fast-paced start-up environment while following SOPs
Benefits For Manufacturing Sciences & Technology (MSAT) Process Engineer, 3rd Shift
- Pre-IPO equity
- Medical, dental, and vision benefits
- Flexible PTO
- 401(k) plan
- Life and accidental death and disability coverage
- Parental leave benefits
- Free daily lunches and snacks at on-site locations
