Automation CSV Engineer
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Automation CSV Engineer (Pharmaceutical)
Horizon Controls Group are looking to hire an experienced Automation Computer System Validation (CSV) Engineer to support pharmaceutical manufacturing systems within a regulated GMP environment. This role is ideal for a validation professional with strong automation exposure who enjoys working at the intersection of compliance technology and operations.
About the Role
The Automation CSV Engineer will be responsible for ensuring that automated control systems are validated and maintained in compliance with regulatory requirements and industry best practices. You will work closely with automation engineers quality IT and manufacturing teams to deliver compliant and inspection-ready systems.
Key Responsibilities
Lead and support CSV activities for automation and control systems
Develop review and execute validation documentation including URS FRS HDS SDS RA IQ OQ PQ
Ensure compliance with GAMP 5 GMP and 21 CFR Part 11 / Annex 11
Support validation of DeltaV DCS PLC SCADA and associated systems
Participate in FAT and SAT activities from a CSV perspective
Perform risk assessments and define validation strategies for new and existing systems
Support audits and regulatory inspections (HPRA FDA EMA)
Manage change control periodic reviews and system lifecycle documentation
Collaborate with automation quality IT and vendor teams
Required Experience & Skills
Proven experience as a CSV Engineer within pharmaceutical or life sciences manufacturing
Strong understanding of automation systems validation
Hands-on experience with validation of DCS / PLC / SCADA systems
In-depth knowledge of GMP GAMP 5 and data integrity principles
Experience working with 21 CFR Part 11 / EU Annex 11 requirements
Excellent documentation and reporting skills
Strong stakeholder engagement and communication abilities
Desirable (Nice to Have)
Experience validating Emerson DeltaV systems
Exposure to MES Historian or laboratory systems
Experience supporting site expansions system upgrades or remediation projects
Familiarity with data integrity assessments and cybersecurity considerations
Company Industry
IT Services and IT Consulting
Key Skills
- Continuous Integration
- APIs
- Automotive software
- Test Cases
- Electrical Engineering
- Junit
- Distributed Control Systems
- Testng
- Java
- Test Automation
- Programmable Logic Controllers
- Selenium
