greenhouse
Engineer I, Process Validation
Arrowhead Pharmaceuticals
Verona, USA
Senior · 8+ years experience
Onsite
USD 90000-120000 / year
Discovered Today
Full Job Posting
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
- Preferred
- 8 years of experience in GMP validation or a related field
- Six Sigma or Lean certifications are a plus.
- Wisconsin pay range $90,000—$120,000 USD
- Arrowhead provides competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.
- California Applicant Privacy Policy
Preferred Qualifications
- Minimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.
- Preferred
- Six Sigma or Lean certifications are a plus.
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.
About Arrowhead Pharmaceuticals
Pharmaceutical Manufacturing711 employeesFounded 2003
Public biopharmaceutical company developing gene-silencing RNAi medicines for patients with intractable diseases.
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Arrowhead Pharmaceuticals
Associate Director, Medical Value, Evidence, and Outcomes (MVEO)
Pasadena, USA
Director
Discovered TodayView →
Senior Director, Quality Control
Verona, USA
Discovered Today
Associate Director, Manufacturing Science and Technology
Verona, USA
Discovered Today
Analyst II, Cyber Security (Operational Technology)
Madison, USA
Discovered Today
Lead, Technical Transfer
Verona, USA
Discovered Today
Associate Director, Medical Value, Evidence, and Outcomes (MVEO)
Pasadena, USA
Discovered Today
Associate Scientist I, In Vivo Research
Madison, USA
Discovered Today
Metrology Technician ll
Verona, USA
Discovered Today
Team Leader, Raw Materials
Verona, USA
Discovered Today