Process Engineer III

Responsibilities

• Support downstream processing unit operations including chromatography, filtration, TFF, buffer generation, and drug product filling
• Assist technology transfer to GMP manufacturing by reviewing process documents, reports, and master batch records
• Provide on-floor support for transfer operations and manufacturing technical support
• Perform root cause analysis and investigations on process or quality discrepancies, deviations, change controls, and CAPAs
• Support process and product life cycle management and continuous process improvement
• Utilize statistical analysis of process data including trending control charts, linear regression, and multivariate analysis

Requirements

• BS/MS in Engineering or a related scientific discipline
• 3-6 years of experience (for BS) or 1-4 years (for MS) in gene therapy or biotechnology
• Experience in process development, analytical development, MSAT, or GMP pharmaceutical manufacturing
• Knowledge of EMA/FDA regulations, ICH guidelines, GMP, and quality systems
• Proficiency in statistical analysis of process data
• Strong written and verbal communication skills
• Experience with project management

Preferred Qualifications

• Experience in viral vaccines or gene therapy
• Experience with technology transfer and GMP manufacturing technical support

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Healthcare, dental, and vision plans
• FSA and HSA programs
• Employer-paid basic term life and personal accident insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to help lead to new cures.