Computer Systems Validation Engineer

We are seeking a CSV Engineer for an 8 month project in the Holly Springs, NC area working for an international professional services and Quality consulting organization, onsite with a biopharma client.

Key Responsibilities:

• Develop and execute validation protocols for computer software systems used in automated process manufacturing equipment, with a specific focus on DeltaV - controlled systems.

• Collaborate with engineering, operations, and quality assurance teams to define validation requirements, ensuring alignment with regulatory standards (e.g., FDA, GMP).

• Perform risk assessments and gap analyses to identify potential areas of concern in the validation process, proposing and implementing mitigation strategies as needed.

• Generate validation documentation, including validation plans, protocols, reports, and traceability matrices, adhering to established procedures and guidelines.

• Conduct testing and verification activities, including software installation qualification (SIQ), operational qualification (OQ), and performance qualification (PQ), in accordance with approved protocols.

• Troubleshoot and resolve validation issues, working closely with technical teams to address any discrepancies or deviations encountered during testing.

• Maintain validation documentation in a compliant and organized manner, ensuring traceability and accessibility for audits and regulatory inspections.

• Stay informed about industry trends, regulatory updates, and advancements in validation methodologies, incorporating best practices into our validation processes.

• Provide technical guidance and mentorship to junior validation engineers, fostering a culture of excellence and continuous improvement within the validation team.

Qualifications:

• Bachelor's degree in Engineering, Computer Science, or related field. Advanced degree preferred.

• 8-10 years of experience in computer software validation, with a focus on automated process manufacturing equipment, particularly DeltaV-controlled systems.

• Proficiency in validation principles and methodologies, with hands-on experience in executing validation protocols in a regulated environment (e.g., FDA, GMP).

• In-depth knowledge of DeltaV automation platform, including configuration, programming, and troubleshooting capabilities.

• Familiarity with regulatory requirements and standards governing automated process manufacturing, such as 21 CFR Part 11, GAMP 5, and IEC 62304.

• Strong analytical and problem-solving skills, with the ability to assess complex technical issues and propose effective solutions.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

• Detail-oriented mindset with a focus on accuracy and compliance in validation documentation and processes.

• Proven track record of successfully leading validation projects and delivering results on schedule and within budget.