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At European Recruitment, our sectors cover a wide range of industries within the field of technology
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range of industries within the field of technology
At European Recruitment, our sectors cover a wide
range of industries within the field of technology
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Senior Automation CSV Engineer (Contract)
Senior Automation CSV Engineer (Contract)
Overview
An experienced Senior Automation CSV Engineer is required to support an onsite automation and computer systems validation (CSV) service within a regulated manufacturing environment. This is an office-hours, onsite contract role, offering competitive daily rates and the opportunity for a long-term assignment on a technically engaging programme of work.
The successful candidate will join a multidisciplinary onsite team, providing CSV expertise across multiple automation and manufacturing systems.
Roles and Responsibilities
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Act as a subject matter expert (SME) for Automation CSV activities, providing guidance and support as required.
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Lead and participate in CSV activities associated with automation and digitalisation projects.
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Prepare and support the full lifecycle of GxP computerised system validation documentation, including:
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Validation Plans
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User & Functional Requirements Specifications
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Risk Assessments
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Qualification Protocols (IQ/OQ/PQ)
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Requirements Traceability Matrices (RTMs)
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Validation Summary Reports
Design, generate, execute, and document test plans and test protocols, including management and reporting of deviations and non-conformances.
Ensure computerised systems and associated documentation comply with site procedures, GMP, and applicable regulatory and industry standards.
Lead and contribute to risk assessments prior to test execution, including (but not limited to) ERES assessments and system functional risk assessments.
Review and assess vendor-supplied validation documentation, including protocols and summary reports.
Support deviation investigations, impact assessments, and change control activities.
Provide technical input and concise advice across a range of automation and CSV-related initiatives.
Skills, Experience, and Education
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Third-level qualification in Electrical, Electronic, Systems Engineering, Computer Science, or equivalent.
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5+ years’ experience in Automation / Control Systems Validation within the Life Sciences or Pharmaceutical sector.
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Strong experience validating PLC, SCADA, and MES systems.
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Excellent technical writing, documentation, and communication skills.
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Solid understanding of:
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GAMP software development lifecycle
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21 CFR Part 11
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ANSI/ISA-88 and ANSI/ISA-95 standards
Proven ability to work independently while collaborating effectively within cross-functional project teams.
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