Manufacturing Investigator II – CAPA & Cross-Functional

FUJIFILM Biotechnologies; Milwaukee (WI); Presencial; USD 90.000 - 130.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical coverage

401(k) plan

Paid time off

Wellness incentives

Resumo da vaga

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to conduct CAPA-driven investigations across Cell Culture, Fermentation, and Downstream programs, ensuring timely closure of events and adherence to quality systems. You will lead cross-functional teams, analyze trends, and prepare regulatory-ready narratives.

The role requires strong problem-solving, technical writing, and communication skills, with experience in cGDPs, cGMPs, and a clinical-to-commercial manufacturing

Qualificações

• Nine+ years of industry experience with relevant investigations or CAPA programs
• Understanding of cGDPs and cGMPs and working in clinical and commercial manufacturing environments

Responsabilidades

• Perform event, minor and major investigations following site and global SOPs
• Identify and implement CAPAs based on root cause analysis
• Lead cross-functional investigational teams including client members
• Track metrics to identify trends and support continuous improvement projects
• Prepare and present investigations to regulators as needed
• Support document revisions and approvals for investigation records
• Provide guidance to junior investigators on investigative techniques and best practices

Conhecimentos

Investigation leadership

Cross-functional collaboration

Root cause analysis

Data analysis

Technical writing

Communication skills

Formação

High School Diploma or equivalent (9 yrs exp)

Associate’s degree (7 yrs exp)

Bachelor’s degree (5 yrs exp)

Master’s degree (3 yrs exp)

Ferramentas

Excel

Word

PowerPoint

Descrição da vaga

FUJIFILM Biotechnologies is seeking an Investigator 2, Manufacturing to conduct CAPA-driven investigations across Cell Culture, Fermentation, and Downstream programs, ensuring timely closure of events and adherence to quality systems. You will lead cross-functional teams, analyze trends, and prepare regulatory-ready narratives.

The role requires strong problem-solving, technical writing, and communication skills, with experience in cGDPs, cGMPs, and a clinical-to-commercial manufacturing