Senior Automation CSV Engineer

United Pharma; Oregon; On-site; USD 120,000 - 150,000; Full time

Job summary

United Pharma is seeking a Senior Automation CSV Engineer to support a major system migration project at a regulated pharmaceutical/biotechnology site.

The ideal candidate has 8+ years of automation and CSV experience, with hands-on expertise in Rockwell and PharmaSuite, and will lead validation activities across PCS, MES, SCADA, and PLC platforms.

Qualifications

• 8+ years of experience in automation and CSV within the pharmaceutical or biotechnology industry.
• Hands-on experience with Rockwell and PharmaSuite.
• Experience with PCS, MES, SCADA, and PLC implementation, migration and validation.
• Strong knowledge of SDLC, CSV, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity.
• Ability to independently lead technical activities.

Responsibilities

• Lead automation and CSV activities for PCS and MES system migration projects.
• Support implementation, configuration, migration, commissioning, and validation of PCS, MES, SCADA, and PLC systems.
• Work with Rockwell, Honeywell, PharmaSuite, POMSnet, and FactoryTalk platforms.
• Prepare and execute validation documents, including validation plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC, and data integrity requirements.
• Manage software changes and maintain validation documentation according to site procedures.
• Troubleshoot system issues and support root cause analysis and deviation investigations.
• Collaborate with Automation, IT, Quality Assurance, and Manufacturing teams.

Skills

Automation

CSV

Rockwell

PharmaSuite

Tools

PCS

MES

SCADA

PLC

Rockwell

PharmaSuite

Job description

We are seeking a Senior Automation CSV Engineer to support a major automation system migration project at a regulated pharmaceutical/biotechnology manufacturing site. The ideal candidate will have 8+ years of experience in automation and Computerized System Validation (CSV), with strong hands‑on expertise in Rockwell and PharmaSuite systems.

Key Responsibilities:

• Lead automation and CSV activities for PCS and MES system migration projects.
• Support implementation, configuration, migration, commissioning, and validation of PCS, MES, SCADA, and PLC systems.
• Work with Rockwell, Honeywell, PharmaSuite, POMSnet, and FactoryTalk platforms.
• Prepare and execute validation documents, including validation plans, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, software development lifecycle (SDLC), and data integrity requirements.
• Manage software changes and maintain validation documentation according to site procedures.
• Troubleshoot system issues and support root cause analysis and deviation investigations.
• Collaborate with Automation, IT, Quality Assurance, and Manufacturing teams.

Required Qualifications:

• 8+ years of experience in automation and CSV within the pharmaceutical or biotechnology industry.
• Hands‑on experience with Rockwell and PharmaSuite
• Experience with PCS, MES, SCADA, and PLC implementation, migration and validation.
• Strong knowledge of SDLC, CSV, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity
• Ability to independently lead technical activities or work status effect