Validation Engineer II

Arrowhead Pharmaceuticals, Inc. (Nasdaq{{:}}  ARWR) is a commercial 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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 

The Position

The Engineer II, Validation will manage and execute commissioning, qualification, and validation (CQV) lifecycle activities supporting  internal GMP drug substance  manufacturing at the Arrowhead Verona site.  This may include CQV programs for equipment, instruments, utilities, facilities, and processes. The Engineer II is responsible to use knowledge of qualification practices to ensure external and internal quality standards are applied and followed, proactively improve the qualification program, and develop a culture of compliance by mentoring others in qualification practices.

Responsibilities

• Creates and maintains site Validation Master Plans, CQV protocols/procedures, and templates for equipment qualification and lifecycle management based on a science and risk-based approach.
• Leads cross functional teams, with some/minimal oversight, through completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced.
• Trains and mentors junior Validation Engineers and internal Subject Matter Experts in Arrowhead and industry best practices for qualification to develop a strong culture of compliance across groups.
• Promotes a strong culture of compliance across groups
• Assists with preparation and maintenance of User Requirements Specifications.
• Prepares and executes installation/operation/performance qualification protocols for new and existing pharmaceutical manufacturing equipment, utilities, and automation systems with some/minimal oversight. Responsible for management of study completion with subject matter expert support and meeting project timeline requirements
• Prepares and reviews CQV reports.
• Independently reviews complex proposed changes for impact to system qualification and validation. Identifies and completes targeted requalification activities to support change completion.
• Establishes internal record keeping system for tracking periodic reviews.  Responsible for completion of periodic reviews per assigned schedules. 
• Maintains qualification documentation in a state of GMP compliance and supports licensee/partner and regulatory site audits throughout the life of a system.
• Authors deviations and corrective action plans for the qualification program. Assigns action items to cross functional team members, guides responsible personnel to effective action item completion, and drives action completion per action plan schedule.   
• Proactively works to identify and manage closure of qualification lifecycle document gaps with developing site CQV program requirements.
• Identifies and proposes process improvement ideas and contributes to the implementation of new process improvement solutions.
• Collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, qualification testing, and deviation resolution.
• Applies knowledge on qualification requirements and practices to lead qualification of unique systems and new technologies.
• Performs other related duties as assigned.

Requirements{{:}}

• Minimum of 12 years of experience in a validation engineering role, preferably in the pharmaceutical drug substance manufacturing industry
• Able to read and understand engineering drawings such as P&IDs, electrical drawings, and functional specifications.
• Bachelor’s degree in Engineering or related scientific field
• Thorough understanding of cGMP and FDA requirements
• Strong communication and documentation skills
• Experience with equipment qualification following ISPE and ASTM guidelines.
• Proficient with Microsoft Office Suite

Preferred

• Prior experience with qualification of equipment integrated with process control systems and qualification of shared equipment in a multi-product facility.
• Prior experience implementing concepts in ISPE Baseline Guide 5, Volume 2 for equipment qualification.
• Familiar with Blue Mountain Regulatory Asset Manager software.

Wisconsin pay range {{:}} $120,000 USD - $145,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.   

All applicants must have authorization to work in the US for a company.   

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