CSV Engineer (onsite a few days a week) (Fordham)

Onsite a few days a week in Fordham.

No relocation offered for this role

Responsibilities

• Validate computerized systems in accordance with 21 CFR Part 11, EU Annex 11, OECD 17, and GAMP 5.
• Support CSV activities of the Quality Management System including deviations, CAPAs, and change controls related to GxP computerized systems.
• Review and create validation documentation – such as risk assessments, user requirements functional specifications, validation plans, IQ/OQ/PQ documentation, traceability matrices, and validation summary reports.
• Collaborate with cross-functional teams, including vendors, IT, Quality Assurance, and Operations, to ensure the successful validation of computer systems and software applications.
• Effectively identify and resolve system issues and appropriately communicate gating items to senior management and stakeholders.
• Support the external audit program for vendors related to GxP computerized systems.
• May support and interface with regulatory agencies and audits as required in support of regulatory agency inspections, including presenting validation strategies and justification of risk-based decisions taken.
• Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements and company policies.
• Continuously improving the CSV process by identifying areas for enhancement and implementing best practices.

Skills, Education & Qualifications

• B.S. degree in Computer Science, Engineering, or relevant scientific field.
• Minimum 2-4 years’ direct validation experience within regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5 requirements.
• Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles.
• Must be able to stay current with industry trends, regulatory changes, and best practices related to CSV to improve inhouse CSV process by identifying areas for enhancement and implementing best practices.
• Must possess understanding of GCP, GLP, and GMP principles and procedures.
• Must possess excellent verbal and written communication skills.
• Proficient in MS Word and other Office applications.
• A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives.Should be an Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.