CSV Lead

Moriah Engineering • Carolina, PR

6d

About The Position

CSV Lead to oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is preferred.

Requirements

• Extensive expertise in validation and compliance
• Computer System Validation (CSV) expertise
• Familiarity with DeltaV
• Familiarity with Aveeva PI
• Experience with GxP guidelines (GMP, GLP, GCP)
• Knowledge of regulatory standards (FDA 21 CFR Part 11, ISO 9001)
• Experience with risk-based validation
• Experience with system integration
• Experience with interface testing
• Experience with data integrity assessments
• Experience with SCADA systems

Nice To Haves

• Background in the biotechnology industry

Responsibilities

• Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.
• Assure the development of the validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure adherence to GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
• Maintain compliance with regulatory standards, including FDA 21 CFR Part 11 and ISO 9001.
• Oversee Computer System Validation (CSV) processes, including risk-based validation, system integration, interface testing, and data integrity assessments.
• Collaborate with cross-functional teams to validate automation systems, including SCADA and Aveeva Pi.
• Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed