Senior Quality Engineer, Biopharma Manufacturing

SaniSure; Camarillo (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

SaniSure, located in Camarillo, CA, seeks a Quality Engineer with extensive experience in the biotechnology sector. This role involves driving quality across manufacturing processes, leading investigations, and supporting regulatory compliance. The successful candidate will ensure product quality through rigorous evaluations and process enhancements.

Additional responsibilities include implementing CAPAs, conducting risk assessments, and engaging with teams for continuous improvement. A Bachelor's degree in a relevant field and over 5 years of experience is required.

Qualifications

• 5+ years of experience in quality operations within relevant industries.
• Experience in GMP or cleanroom environments.
• Strong skills in CAPA, change control, and validation.

Responsibilities

• Lead quality investigations and implement corrective actions.
• Conduct risk assessments and ensure closure of quality events.
• Collaborate with teams to improve processes and quality.

Skills

Quality systems management

Continuous improvement methodologies

Cross-functional teamwork

Technical writing

Problem-solving

Education

Bachelor’s degree in Engineering or related field

Tools

Microsoft Office

Job description

SaniSure, located in Camarillo, CA, seeks a Quality Engineer with extensive experience in the biotechnology sector. This role involves driving quality across manufacturing processes, leading investigations, and supporting regulatory compliance. The successful candidate will ensure product quality through rigorous evaluations and process enhancements.

Additional responsibilities include implementing CAPAs, conducting risk assessments, and engaging with teams for continuous improvement. A Bachelor's degree in a relevant field and over 5 years of experience is required.