Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd Shift

$80,000 - $90,000/Yr

Orca Bio - Sacramento, CA

Full-time - Mid Level

Sacramento, CA

Computer and Electronic Product Manufacturing

About the position

The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. This is a 2nd Shift/Swing position with a Monday through Friday schedule from 3-11:30pm.

Responsibilities

• 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

• 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, with a desire to improve upon established processes

Nice-to-haves

• Highly detail oriented with special attention to quality, compliance and safety
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Demonstrates strong work ethic, curiosity to learn and contribute
• Strong interpersonal skills and ability to communicate effectively
• Ability to work in a collegial and collaborative manner, independently and as part of a team
• Ability to work in a fast-paced start-up environment while following SOPs
• Highly tolerant and respectful of all team members
• A sense of humor is always appreciated

Benefits

• $80,000 - $90,000 a year
• Eligible to receive 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