Salary Range: 80000 to 90000 (Currency: USD) (Pay period: per-year-salary)

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 

Education & Experience 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 

Personal Qualities & Physical Demands

• 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 
• Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition 
• Occasional need to ascend/descend stairs within workspace; job requires standing/walking