CSV Lead

at  SimoTech

ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

CSV LEAD 1519

SimoTech is seeking a CSV Lead to join our team supporting a major biotech manufacturing facility for our biopharmaceutical client based in Limerick. You will join a state-of-the-art facility, incorporating new technologies with a specific focus on operational flexibility, environment sustainability and fast track delivery concepts. The plant will be automated with full batch sequencing and recipes using DeltaV DCS.
As the CSV Lead, you support the automation team with associated documentation, lead the CSV strategy and planning, and you will also work collaboratively with various technical teams across Automation, Quality Assurance and System Integrator teams.
The ideal candidate will have a minimum of 10 years’ experience in CSV (Computer System Validation) within the pharmaceutical industry. The role can initially be fully remote for the first 12 months, with site visits required as the project progresses.

QUALIFICATIONS

• Bachelor’s Degree in Engineering, Information Systems, Computer Science or Life Sciences.
• Minimum 10 years’ experience working on CSV in a Life Sciences manufacturing industry, preferably BioPharma.
• Experience working on MS Office Suite.
• Extensive knowledge on GMPs, regulatory requirements and computer system validation.
• Experience in Automation and DCS DeltaV.
• Knowledge on the KNEAT validation software is preferred.
• Excellent written and verbal communication skills for both technical and non-technical audiences.

• Oversee and support the System Integrator (SI) team in developing DeltaV DCS application software and documentation.
• Review, approve and manage SI deliverables including Requirements Design, Testing documents, Change Management, and Supplier Management Plans.
• Ensure compliance of SI deliverables with CSV expectations, collaborating on DeltaV DCS configurations and data historian setups.
• Work with Quality, Engineering, Commissioning teams to align project deliverables.
• Oversee document management and streamline CSV documentation for project holders.
• Manage approvals for key documents, such as Backup & Restoration and Disaster Recovery Plans Conduct Supplier, Risk, and Data Integrity Assessments to ensure regulatory compliance.
• Develop and document CSV strategies to ensure compliance with quality and regulatory standards.