Lead Reagent Bulk & Fill Technician

Grifols, S.A; San Diego (CA); On-site; USD 50,000 - 63,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Job summary

Grifols Diagnostic Solutions in San Diego, CA is seeking a Reagent Bulk & Fill Technical Specialist for a variable shift. The role covers bulk formulation, materials preparation, and assembly for clinical and commercial kits, with strong emphasis on cGMP and QA documentation.

You will mentor technicians, lead process improvements, and ensure accurate device history records while collaborating with cross-functional teams to meet production timelines and quality standards.

Qualifications

• At least 8 years in reagent fill or bulk formulation in a regulated setting.
• At least 5 years troubleshooting fill/bulk equipment in a controlled environment.
• 4+ years with GDP, cGMP and ISO 13485 requirements.
• Mechanical certification is a plus.

Responsibilities

• Lead troubleshooting and operation of reagent filling equipment and processes.
• Coordinate bulking, filling, aliquoting, and packaging for clinical and commercial kits.
• Oversee document updates for DHR, SOPs, and device history records.
• Mentor Reagent Bulk & Fill Technicians across all levels and train staff.
• Ensure cGMP compliance and audit readiness through thorough documentation.
• Support CAPA discussions and cross-functional process improvements.

Skills

Bulk/formulation

Troubleshooting

GMP knowledge

Documentation

SAP

Education

High School Diploma or GED

Associates degree preferred

Tools

DHR

SOPs

Job description

Grifols Diagnostic Solutions in San Diego, CA is seeking a Reagent Bulk & Fill Technical Specialist for a variable shift. The role covers bulk formulation, materials preparation, and assembly for clinical and commercial kits, with strong emphasis on cGMP and QA documentation.

You will mentor technicians, lead process improvements, and ensure accurate device history records while collaborating with cross-functional teams to meet production timelines and quality standards.