Plant Operations
Process Validation Engineer
Office Location: Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
We are seeking a highly skilled and motivated Process Validation Engineer with a strong background in Good Manufacturing Practices (GMP) to join our team. This individual will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation. The ideal candidate will have a minimum of 8 years of experience in GMP validation or related fields, with at least 3 years of GMP manufacturing experience preferred.
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
- 5 years of experience in GMP validation or a related field
- 3 years of GMP manufacturing experience
- 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.
- Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
- Excellent problem-solving skills and attention to detail.
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Experience with regulatory submissions and/or inspections.
- Experience in a pharmaceutical or biopharmaceutical manufacturing environment.
Preferred:
- Six Sigma or Lean certifications
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.