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.