Associate Engineer, cGMP Computer Systems Validation

ZipRecruiter; Verona; In loco; EUR 68.000 - 82.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company is seeking a Quality Systems Validation professional to manage validation processes for computerized systems. The ideal candidate will have a Bachelor's degree in science, relevant certifications, and at least 5 years of experience in the pharmaceutical sector, ensuring compliance and integrity of data for CSV projects. The position offers a competitive salary of $80,000—$95,000 USD and excellent benefits.

Servizi

Competitive salaries

Excellent benefits

Competenze

• At least 5 years of experience in a pharmaceutical/biotech company or CRO.
• Experience with computerized systems, equipment, or instruments qualification.

Mansioni

• Provide Quality guidance for CSV efforts.
• Review and approve validation documentation.
• Serve as SME for CSV.

Conoscenze

Quality guidance for CSV efforts

Risk assessments

Data integrity assessments

Formazione

Bachelor's degree in an applicable science field

Quality certifications such as CQA, CQMP

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 delivery modes, Arrowhead therapies trigger RNA interference (RNAi) to induce rapid, deep, and durable knockdown of target genes. RNAi is a natural mechanism in cells that inhibits specific gene expression, affecting protein production. Arrowhead's therapeutics leverage this pathway to address diseases, especially those with genetic bases involving overproduction of proteins.

Headquartered in Pasadena, CA, with research teams in Madison, WI, and San Diego, CA, and a manufacturing facility in Verona, WI, our employees are innovative, science-driven, and collaborative, committed to developing new therapies for patients.

The Position

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

Responsibilities

• Provide Quality guidance for CSV efforts, including requirements engineering, risk assessments, and data integrity assessments.
• Review and approve validation documentation such as Validation Plans, Requirements Specifications, Risk Assessments, Testing Protocols, and Summary Reports.
• Serve as an SME for CSV, maintaining expertise in computer system validation.
• Review CSV documentation to ensure data integrity requirements are met.
• Assess and approve discrepancies or deviations during qualification and validation activities.
• Review and approve change controls for computerized systems.
• Coordinate validation activities with stakeholders.
• Provide direction to validation contractors if applicable.
• Support audits by communicating CSV approaches.
• Assist in regulatory inspections and readiness activities.
• Review and approve periodic validation reviews and address gaps with remediation plans.

Requirements:

• Bachelor's degree in an applicable science field.
• Quality certifications such as CQA, CQMP are preferred.
• At least 5 years of experience in a pharmaceutical/biotech company or CRO, with responsibilities related to computerized systems, equipment, or instruments qualification.
• Knowledge of GMP, GLP, FDA, EU, and ICH regulations.

Additional:

• Experience with electronic document management systems in regulated environments is desirable.

Salary range in Wisconsin: $80,000—$95,000 USD.

Arrowhead offers competitive salaries and excellent benefits.

Applicants must have authorization to work in the US.

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