Responsibilities:

• Lead and manage computer system validation (CSV) projects, including authoring and executing specifications and validation documentation for enterprise systems.
• Develop and author validation protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies.
• Perform reviews and remote execution of validation protocols in accordance with cGMP, ISPE GAMP 5, and corporate standards.
• Ensure data integrity, system security, access control, and user safety are adequately addressed within validation documentation.
• Conduct risk assessments and prepare validation summary reports aligned with GMP and regulatory requirements.
• Investigate and support resolution of Deviations, CAPAs, and other quality system activities, including Periodic Reviews.
• Create comprehensive validation deliverables, including plans, specifications, protocols, traceability matrices, and change controls.
• Validate software for manufacturing instruments while managing up to four concurrent validation projects.
• Waters/Empower/OSI PI/MODA/Unicorn/Process Pad or products serving the same function.
• Various Manufacturing Instruments Software.
• Other Enterprise Applications as Required.

Requirements:

• 7+ years of experience in FDA-regulated industries with strong knowledge of GMP, 21 CFR Part 11, and Annex 11.
• 5+ years of experience in document authoring, SOP revisions, and protocol re-execution.
• Demonstrated ability to manage multiple concurrent validation or system implementation projects.
• Experience validating software for manufacturing instruments, as well as enterprise systems such as SAP, Empower, and Veeva or similar.
• Proficient in both traditional (V-Model) and modern (CSA) validation approaches.
• Familiarity with Agile and Waterfall methodologies in system and software development environments.
• Excellent written and verbal communication skills; strong collaborator with cross-functional teams.
• Self-motivated, adaptable, and customer-focused, with a proactive approach to leadership and problem-solving.
• BS/BA required in a related field.
• 5+ years minimum required relevant experience.

• Lead and manage computer system validation (CSV) projects, including authoring and executing specifications and validation documentation for enterprise systems.
• Develop and author validation protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies.
• Perform reviews and remote execution of validation protocols in accordance with cGMP, ISPE GAMP 5, and corporate standards.
• Ensure data integrity, system security, access control, and user safety are adequately addressed within validation documentation.
• Conduct risk assessments and prepare validation summary reports aligned with GMP and regulatory requirements.
• Investigate and support resolution of Deviations, CAPAs, and other quality system activities, including Periodic Reviews.
• Create comprehensive validation deliverables, including plans, specifications, protocols, traceability matrices, and change controls.
• Validate software for manufacturing instruments while managing up to four concurrent validation projects.
• Waters/Empower/OSI PI/MODA/Unicorn/Process Pad or products serving the same function.
• Various Manufacturing Instruments Software.
• Other Enterprise Applications as Required