Horizon Controls Group are seeking a highly skilled and experienced Automation Systems Validation Engineer (CSV) to join our dynamic team. The CSV Engineer will be responsible for ensuring the compliance of automation systems, including DeltaV, Rockwell, and Siemens PLCs, with regulatory requirements within our highly automated and highly regulated biotech plant.

• Develop and execute validation protocols and test scripts for automation systems, including the DeltaV platform (DCS), Rockwell, and Siemens PLC-based control systems.

• Perform risk assessments and impact analyses to determine the criticality of automation systems and identify validation requirements.

• Collaborate with automation engineers, process engineers, and quality assurance professionals to develop validation strategies and documentation in accordance with regulatory guidelines (e.g., FDA, GMP, GAMP).

• Conduct IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) activities for new automation systems and equipment.

• Execute periodic revalidation activities and manage change control processes for automation systems to ensure ongoing compliance.

• Troubleshoot and resolve issues related to automation systems validation, including deviations, discrepancies, and non-conformances.

• Provide technical expertise and guidance to cross-functional teams on validation best practices and regulatory requirements.

• Utilize the Kneat online validation platform for efficient and streamlined validation documentation management and execution.

Qualifications:

• Bachelor’s degree in engineering or related field; advanced degree preferred.

• Minimum of 5 years of experience in validation and qualification of automation systems within the biotech or pharmaceutical industry.

• Proficiency in validation principles and methodologies, including risk-based validation approaches.

• Hands-on experience with the DeltaV DCS platform and familiarity with other automation platforms such as Rockwell and Siemens PLCs.

• Experience of utilising and configuring Kneat online validation platform is essential.

• Strong understanding of regulatory requirements (e.g., FDA, GMP, GAMP) related to automation systems validation in the biotech industry.

• Experience with validation documentation, including validation plans, protocols, reports, and traceability matrices.

• Excellent problem-solving skills and attention to detail.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.

If this position is of interest to you please apply by sending your CV to MNikolova@Horizon-Controls.com or alternatively give me a call on 087-668-8267.

ASV Engineer (Automation Systems Validation)