Validation Engineer

R&D Partners; Town of Florida (NY); On-site; USD 85,000 - 90,000; Full time

Job summary

R&D Partners in the United States is seeking a Validation Engineer to support the development, implementation, and execution of validation strategies for equipment and computerized systems in a regulated pharma environment.

You will qualify equipment, validate software, and maintain accurate documentation to meet quality and compliance requirements, including GAMP5 and 21 CFR Part 11.

Qualifications

• Experience with validation testing (IQ, OQ, PQ) and change control processes.
• Familiarity with ISPE Baseline Guide, GAMP5 and FDA regulations.
• Ability to create and manage technical documentation.
• Knowledge of ALCOA data integrity principles.

Responsibilities

• Help create and implement validation strategies following industry guidelines and regulations.
• Assist in assessing the impact of systems and classifying equipment.
• Develop and execute plans for validating equipment and software systems.
• Create, review, and manage documents like system requirements, design reviews, and qualification protocols (IQ, OQ, PQ).
• Use vendor-provided documentation effectively during validation processes.
• Ensure all documentation is accurate, complete, and meets compliance standards.
• Address and document any issues or deviations during validation activities.
• Support change control processes and requalification efforts.
• Participate in risk assessments and apply risk-based approaches to validation tasks.
• Contribute to CSV for software and embedded systems.
• Ensure software systems comply with GAMP5 and 21 CFR Part 11.
• Design and conduct validation tests for software systems and maintain related documentation.

Skills

Validation strategies for equipment

Documentation management

ISPE Baseline Guide familiarity

GAMP5 knowledge

FDA regulations knowledge

IQ/OQ/PQ testing

ALCOA data integrity

Risk-based validation

Job description

Keep the heartbeat of innovation running! Join our client in this engineering position and ensure cutting-edge pharma never misses a beat!

R&D Partners is seeking a Validation Engineer to support the development, implementation, and execution of validation strategies for equipment and computerized systems. This role focuses on ensuring compliance with industry standards, regulatory expectations, and internal policies. You will play a key role in qualifying equipment, validating software systems, and maintaining accurate documentation to meet quality and compliance requirements.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Help create and implement validation strategies following industry guidelines and regulations.
• Assist in assessing the impact of systems and classifying equipment.
• Develop and execute plans for validating equipment and software systems.
• Create, review, and manage documents like system requirements, design reviews, and qualification protocols (e.g., IQ, OQ, PQ).
• Use vendor-provided documentation effectively during validation processes.
• Ensure all documentation is accurate, complete, and meets compliance standards.
• Address and document any issues or deviations during validation activities.
• Support change control processes and requalification efforts.
• Participate in risk assessments and apply risk-based approaches to validation tasks.
• Contribute to computerized system validation (CSV) for software and embedded systems.
• Ensure software systems comply with industry regulations, such as GAMP5 and 21 CFR Part 11.
• Design and conduct validation tests for software systems and maintain related documentation.

Key Skills and Requirements:

• Strong understanding of validation processes for equipment and software systems.
• Familiarity with industry standards like ISPE Baseline Guide, GAMP5, and FDA regulations.
• Ability to create and manage technical documentation.
• Knowledge of risk-based approaches to validation and data integrity principles (e.g., ALCOA).
• Experience with validation testing (IQ, OQ, PQ) and change control processes.
• Strong organizational and problem-solving skills.

Compensation:

• $85,000 to $90,000 per annum.

For more information, please contact Jack Keens.