Associate Engineer, cGMP Computer Systems Validation

ZipRecruiter; Verona; In loco; EUR 60.000 - 75.000; Tempo pieno

Descrizione del lavoro

A biopharmaceutical company based in the US is seeking a Quality Compliance Specialist to support cGMP, GLP, and GCP-regulated operations. The role involves providing validation support for computerized systems and ensuring compliance with industry regulations while serving as a subject matter expert. Candidates should possess a relevant science degree and have extensive experience in quality compliance in the pharmaceutical industry.

Servizi

Competitive salaries and excellent benefits

Competenze

• 5+ years of experience in a relevant field.
• Familiar with GMP and GLP regulations.
• Experience in validation processes and compliance.

Mansioni

• Guide and approve validation documentation for computerized systems.
• Serve as SME for CSV, ensuring compliance and data integrity.
• Coordinate validation activities with stakeholders.

Conoscenze

Quality Compliance

Data Integrity

Risk Assessment

Formazione

Bachelor's degree in Science

CQA or CQMP Certification

Strumenti

Electronic Document Management Systems

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to 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 proteins involved in disease. The depth and versatility of our RNAi technologies enable us to address conditions in various therapeutic areas, including targets not accessible by small molecules and biologics. Arrowhead is leading in bringing RNAi therapies outside of the liver, with clinical pipeline targets in liver and lung, and a promising pipeline of preclinical candidates.

Our 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 collaborating to bring new therapies to patients in need.

The Position

This role supports the cGMP, GLP, and GCP-regulated Quality organization by providing validation and lifecycle support for computerized systems, software, and IT infrastructure that are newly installed, upgraded, replaced, or modified. The incumbent will guide, generate, review, and approve system assessments, test scripts, change controls, process improvements, and data integrity and governance throughout the system lifecycle. The position also serves as a subject matter expert, providing compliance leadership and oversight for CSV projects, working with business partners to enhance computer system validation processes.

Responsibilities

• Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments.
• Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports.
• Serves as an SME for CSV and maintains expertise in the Computer System Validation area.
• Ensures data integrity requirements are maintained during CSV documentation review.
• Reviews and approves discrepancies or deviations during qualification or validation activities.
• Reviews and approves computerized system change controls.
• Coordinates validation activities with key stakeholders.
• Provides direction to validation contractors as needed.
• Communicates CSV approach during audits.
• Prepares documentation and supports regulatory inspections and readiness activities.
• Reviews and approves periodic system validation reviews and ensures remediation plans for identified gaps.

Requirements

• Bachelor's degree in an applicable science field.
• Additional Quality certifications such as CQA or CQMP are desirable.
• Minimum of 5 years of experience in a pharmaceutical, biotech, contract manufacturing, or research organization with responsibilities related to computerized system, equipment, or instrument qualification.
• Working knowledge of GMP and/or GLP FDA, EU, and ICH regulations.

Additional Information

• Experience with electronic document management systems in a regulated environment is preferred.

Wisconsin pay range: $80,000—$95,000 USD.

Arrowhead offers competitive salaries and excellent benefits.

Applicants must have authorization to work in the US.

California Applicant Privacy Policy applies.