CSV Engineer 1739

SimoTechnology; Leinster; In loco; EUR 65.000 - 95.000; Tempo pieno

Descrizione del lavoro

SimoTech in Ireland is seeking a seasoned CSV Engineer to support validation for a Drug Product Facility project with a biopharmaceutical client in Co. Dublin. The role is fully onsite, requiring strong GMP and CSV experience.

You will author and manage validation documentation, coordinate with SMEs, vendors and quality teams, and ensure compliance with EU/US regulatory standards.

Competenze

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 6 years’ experience in GMP and validation disciplines, with strong understanding of pharmaceutical design, build, commissioning, and validation processes and their alignment with EU and US FDA requirements.
• Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
• Solid understanding of computer systems and PLC automation systems, enabling FAT and IOQ protocols with SME support.
• Experience with MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
• Experience with Kneat paperless validation systems would be an advantage.
• Demonstrate excellent interpersonal and communication skills, with attention to detail and ability to work across cross-functional teams.

Mansioni

• Responsible for authoring and managing the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
• Monitor FAT and IOQ execution activities, ensuring alignment with test script intent and resolving protocol issues while executing CSV tests on lines and equipment.
• Ensure all automation deliverables comply with regulations and industry best practice standards.
• Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM and summary reports.
• Develop and maintain templates for all SDLC deliverables in compliance with client standards, including Requirements Specifications, RTM, Functional Specifications, Data Integrity, Design Specifications, Code Reviews, and Test Scripts.
• Conduct system walkdowns and verification of technical documentation and drawings (P&IDs, as-built drawings) for accuracy and compliance.
• Identify risks and recommend improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.

Conoscenze

GMP validation

CSV documentation

Cross-functional collaboration

FDA/regulatory knowledge

Attention to detail

Formazione

Bachelor’s degree in Engineering or Life Sciences

Strumenti

Kneat

MES

PLC automation systems

Descrizione del lavoro

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients’ life-changing supply ofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.

SimoTech has a new opportunity for a CSVEngineer to join our team, supporting the validation for a Drug ProductFacility project for our biopharmaceutical client based in Co. Dublin.

The successful candidate will have a minimum of6 years’ experience in developing and validating automation documentation andworking closely with SMEs, vendors, & quality teams to ensure compliancewith regulations, timelines and operational needs. This is a fully onsite role.

Key Responsibilities

• Responsible for authoring and managing the C&Qplan, PCS automation validation plans, URS, FAT, IOQ documentation and summaryreports, in collaboration with cross-functional teams.
  
• Monitor FAT and IOQ execution activities, ensuringalignment with test script intent, identifying & resolving protocol issuesand executing CSV related tests on lines and equipment.
  
• Ensure all automation deliverables comply withregulations and industry best practice standards.
  
• Maintain consistency and traceability across C&Qplans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM and summary reports.
  
• Develop and maintain templates for all SDLCdeliverables in compliance with client standards, ensuring consistentimplementation of validation strategies. Deliverables include, but are notlimited to, Requirements Specifications, Requirements Traceability Matrices(RTM), Functional Specifications, Data Integrity Assessments, DesignSpecifications, Code Reviews, and Test Specifications/Test Scripts.
  
• Conduct system walkdowns and verification oftechnical documentation and drawings, including P&IDs, as-built drawings,and related engineering documentation, to ensure accuracy and compliance.
  
• Identify risks and recommend improvements to theC&Q and automation qualification strategy, documentation quality, and testexecution.
  
• Share key learnings to facilitate effectiveknowledge transfer for future projects.
  

Requirements

Key Requirements

• Bachelor’sdegree in Engineering, Computer Science, Life Sciences or similar.
  
• Minimum6 years’ experience in GMP and validation disciplines, with a strongunderstanding of pharmaceutical design, build, commissioning, & validationprocesses, and their alignment with EU and US FDA regulatory requirements.
  
• Knowledgeof regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
  
• Solidtechnical understanding of computer systems and PLC automation systems,enabling FAT and IOQ protocols to be authored with support from other SMEs.
  
• Experienceworking with one or more of the following systems: MES, PI Data Historian, PCS,Lab systems, QBMS, or inspection line control systems.
  
• Experienceworking with paperless validation systems (Kneat) would be an advantage.
  
• Demonstrateexcellent interpersonal and communication skills, with strong attention todetail and the ability to work effectively across cross-functional teams.
  

What SimoTech CanOffer

• Role provides a high degree of autonomy to allow the successfulcandidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working withinnovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capitalprojects.