Engineer I, Process Validation

About the role

The Process Validation Engineer will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation. Arrowhead Pharmaceuticals develops RNAi‑based therapeutics and operates from headquarters in Pasadena, CA with R&D teams in Madison, WI and San Diego, CA, and a manufacturing facility in Verona, WI.

Responsibilities

• Draft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations.
• Oversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met.
• Collaborate with cross‑functional teams to ensure validation strategies align with production requirements and regulatory guidelines.
• Provide technical support to manufacturing during validation and qualification activities.
• Identify and assess risks, proposing corrective actions and improvements to enhance validation processes.
• Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines.
• Review and approve validation data and documentation to ensure accuracy and regulatory compliance.
• Participate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies.
• Provide training and mentorship to employees on validation processes and GMP standards.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
• Excellent technical writing skills with high attention to detail.
• Proficiency in Microsoft Word and Excel.
• Ability to work across teams.
• Experience in drafting and reviewing validation protocols and reports.
• Strong understanding of GMP regulations, validation principles, and industry best practices.
• Minimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.
• Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
• Excellent problem‑solving skills and attention to detail.
• Experience with regulatory submissions and/or inspections.
• Experience in a pharmaceutical or biopharmaceutical manufacturing environment.
• Experience working in a GMP setting.
• Experience with controlled documentation.

Qualifications

• Preferred: 8 years of experience in GMP validation or a related field.
• Six Sigma or Lean certifications are a plus.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Pay

Wisconsin pay range: $90,000 USD – $120,000 USD.