Validation Engineer – CSV and Compliance Support

Join our client where engineering meets impact! Your next career jump in engineering could be right at your fingertips.

R&D Partners is seeking a Validation Engineer focusing on CSV and Compliance to support the lifecycle management of computer systems used in pharmaceutical operations. You will work closely with system owners to ensure compliance, perform maintenance, and create necessary documentation for validation and system integrity.

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Assist system owners with tasks related to maintaining and validating computer systems.
• Create and update documentation for system validation and lifecycle support.
• Perform annual system maintenance activities, including creating and reviewing test protocols.
• Manage quality records such as CAPAs, deviations, and planned events, ensuring timely completion.
• Conduct periodic system reviews by analyzing past events and assessing their impact on system validation.
• Support system procurement, development, integration, operation, and retirement processes.
• Help with system upgrades, patches, and changes to maintain compliance.
• Generate reports and assist with administrative tasks like document formatting and routing.
• Collaborate with global and local teams to align with validation protocols and policies.
• Attend quality meetings and provide metrics to ensure compliance.

Key Skills and Requirements:

• Background in computer science, engineering, life sciences, or a related field.
• Familiarity with computer system validation frameworks (CSV/CSA) and GAMP principles.
• Knowledge of systems like SCADA, OSI-PI, DeltaV, MES, and other manufacturing execution tools.
• Understanding of regulatory guidelines such as FDA 21 CFR Part 11, EU GMP Annex 1, and data integrity principles.
• Experience with system administration, recipe authoring, and risk assessment concepts.
• Strong organizational and communication skills to collaborate with diverse stakeholders.

Compensation:

• $74 to $94 per hour.

For more information, please contact Jack Keens.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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