Lead CSV Engineer

Horizon Controls Group; Tipperary; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading engineering firm in Tipperary is seeking a CSV engineer to oversee Computer System Validation. The successful candidate will collaborate with project teams, ensuring compliance with regulatory standards while developing key documents like Qualification Plans and Test Plans. Ideal applicants will have at least 3 years of experience in life sciences, expertise in GAMP5, and proficiency with systems such as Emerson DeltaV. Strong communication skills and a relevant degree are essential for this role.

Qualifications

• Minimum of 3 years' experience in a similar role in life sciences.
• Experience in pharmaceutical manufacturing is ideal.
• Previous experience with paperless validation systems (Kneat) is advantageous.

Responsibilities

• Develop and maintain Qualification Plans and Test Plans.
• Work closely with the Digital Data and Quality function.
• Provide guidance and support to team members.

Skills

Expert knowledge of GAMP5

Emerson DeltaV

Excellent computer skills

Strong interpersonal skills

Education

Relevant Computer Science or Engineering degree or equivalent

Tools

Excel

SharePoint

Word

PowerPoint

Job description

Tipperary, Ireland | Posted on 12/03/2025

Overview

Reporting to the Project Manager and CSV Lead, the CSV engineer will be responsible for Computer System Validation. The CSV engineer will develop key quality documents such as QAPs test plans, Requirements Traceability Matrices and Quality assurance summary reports, ensuring adherence to regulatory standards. The role requires close collaboration with teams responsible for full Automation and IT scope, vendors and partners delivering systems, and representing the CSV function at Automation, IT and other project meetings as required.

The successful candidate will act as the CSV SME for the project team, providing a standardized CSV approach across capital projects, as defined by the CSV lead.

Responsibilities

• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the 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.
• Approval of 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 the various stakeholders on the overall project to ensure clear communication between all parties in relation to validation requirements.

Qualifications

• Minimum of 3 years’ experience in a similar role in life sciences, ideally in pharmaceutical manufacturing.
• Expert knowledge of GAMP5.
• Experience in the following systems is essential: Emerson DeltaV.
• Experience in the following systems would be advantageous: DCS, Siemens PLC/SCADA, OSISoft PI, Werum Pax‑X.
• Excellent computer skills, proficient in the use of the following Microsoft tools: 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) will be advantageous.