Automation CSV Engineer

• The Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment.
• Support validation and lifecycle management activities for GMP automation systems including DeltaV, PI, SCADA, PLC, and associated manufacturing control platforms.
• Assist in ensuring automation systems remain compliant with GxP regulations, internal procedures, and industry standards throughout the system lifecycle.
• Participate in implementation, upgrade, patching, migration, and change control activities for automation systems.
• Execute and support commissioning, qualification, and validation testing activities including FAT, SAT, IQ, OQ, PQ, and automation functional testing.
• Document test execution results, discrepancies, deviations, and corrective actions in accordance with approved procedures.
• Collaborate with system owners and technical SMEs to gather system requirements and support risk assessments for automation systems.
• Support periodic reviews, audit readiness activities, and inspection support for validated automation systems.

• Bachelor’s degree in Engineering, Computer Science, Biotechnology, Information Systems, or related technical discipline preferred.
• Minimum of 5 years of experience supporting GMP automation systems, computer system validation (CSV), automation testing, or technical writing activities within regulated industries.
• Hands‑on experience with automation platforms such as DeltaV, PI, SCADA, PLC, or related manufacturing systems.
• Experience executing validation and qualification activities including FAT, SAT, IQ, OQ, PQ, and functional testing.
• Strong technical writing skills with experience authoring validation documentation and compliance records.
• Working knowledge of GxP regulations and industry guidance including: 21 CFR Part 11, Annex 11, GAMP 5, FDA CSA principles, Data Integrity requirements.
• Understanding of automation system lifecycle management and pharmaceutical quality systems.
• Experience supporting change controls, deviations, CAPAs, and risk assessments within GMP environments.
• Strong organizational skills and attention to detail with the ability to manage multiple assignments simultaneously.
• Effective communication and collaboration skills with the ability to work across technical and business functions.

Demonstrates expertise in supporting GMP automation systems, including validation, compliance, and technical documentation, while ensuring adherence to GxP regulations and industry standards. Proficient in executing validation activities and managing automation system life cycles within regulated environments.

• GMP Automation Systems Support
• Computer System Validation (CSV)
• Validation Testing Activities (FAT, SAT, IQ, OQ, PQ)
• Technical Writing for Validation Documentation
• GxP Regulations Knowledge

• GMP Automation Systems
• Computer System Validation (CSV)
• Validation Testing (FAT, SAT, IQ, OQ, PQ)
• Technical Writing
• Automation Platforms (DeltaV, PI, SCADA, PLC)
• Lifecycle Management
• Change Control
• Risk Assessment
• Deviation Management
• CAPA Support

• Organizational Skills
• Attention to Detail
• Effective Communication
• Collaboration Skills

• GxP Regulations
• 21 CFR Part 11
• Annex 11
• GAMP 5
• FDA CSA Principles
• Data Integrity
• Pharmaceutical Quality Systems