Lead CSV Engineer

Horizon Controls Group; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading life sciences company in Ireland is looking for a Computer System Validation Specialist. The role involves developing key quality documents, ensuring compliance with regulatory standards, and collaborating with various stakeholders. Ideal candidates have a minimum of 3 years' experience in pharmaceutical manufacturing, expert knowledge of GAMP5, and proficiency in Emerson DeltaV. Excellent communication and interpersonal skills are also required. This role offers an opportunity to directly contribute to the quality and compliance of vital systems.

Qualifications

• Minimum of 3 years’ experience in a similar role in life sciences.
• Expert knowledge of GAMP5.
• Experience with Emerson DeltaV is essential.
• Strong interpersonal and communication skills.
• Relevant Computer Science or Engineering degree or equivalent.

Responsibilities

• Responsible for all Computer System Validation activities.
• Develop key quality documents ensuring regulatory compliance.
• Review and ensure vendor compliance with quality standards.
• Approve all SDLC deliverables.
• Provide guidance and support to team members.

Skills

Expert knowledge of GAMP5

Interpersonal and communication skills

Proficient in Microsoft Excel

Proficient in SharePoint

Proficient in Word

Proficient in PowerPoint

Education

Relevant Computer Science or Engineering degree

Tools

Emerson DeltaV

DCS

Siemens PLC/SCADA

OSISoft PI

Werum Pax‑X

Job description

Tipperary, Ireland | Posted on 12/03/2025

Responsibilities

• Reporting to the Project Manager and CSV Lead, specifically responsible for Computer System Validation.
• Develop key quality documents such as Quality Assurance (QAPs) test plans, Requirements Traceability Matrices, and Quality assurance summary reports, ensuring adherence to regulatory standards.
• Work closely with teams responsible for the full Automation and IT scope and with vendors/partners responsible for delivery of systems.
• Review and ensure vendor compliance with quality standards.
• Represent the CSV function at Automation, IT and other project meetings, as required.
• Act as the CSV SME for the project team and provide a standardized CSV approach across capital projects, as defined by the CSV lead.
• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and leveraging strategy.
• Develop templates for all SDLC deliverables, compliant with MSD standards, to ensure consistent implementation of the validation strategy, including but not limited to:
  • Requirements Specification
  • Requirements Traceability Matrix
  • Functional Specification
  • Design Specification
  • Test specification/test script
• Work closely with the Digital Data and Quality (DDQ) function and ensure their requirements are met.
• Approve all SDLC deliverables, ensuring compliance with standards.
• Provide FAT oversight and perform leveraging assessments.
• Provide guidance and support to team members tasked with delivery of SDLC documents.
• Provide input to the development of realistic project schedules and document trackers.
• Work closely with suppliers/integrators to ensure compliance with MSD standards.
• Participate in, and support, relevant project meetings.
• Liaise with various stakeholders to ensure clear communication between all parties regarding validation requirements.

Qualifications

• Minimum of 3 years’ experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.
• Expert knowledge of GAMP5.
• Experience with Emerson DeltaV (essential).
• Experience with DCS, Siemens PLC/SCADA, OSISoft PI, Werum Pax‑X (advantageous).
• Excellent computer skills, proficient in Microsoft Excel, SharePoint, Word, and PowerPoint.
• Strong interpersonal and communication skills (verbal and written).
• Relevant Computer Science or Engineering degree or equivalent.
• Previous experience working with paperless validation systems (Kneat) advantageous.