CSV Engineer

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development - empowering our team members to grow personally and professionally.

Position Overview

The CSV (Computer System Validation) Engineer is responsible for ensuring that computerized systems used in regulated environments are validated and maintained in compliance with applicable regulatory requirements and company standards. This role supports the full validation lifecycle, including planning, execution, documentation, and maintenance of validation activities for systems such as MES, BAS, and process control systems. The CSV Engineer works closely with cross-functional teams to ensure system reliability, data integrity, and compliance with cGxP guidelines while supporting project timelines and operational readiness.

Key Responsibilities

• Develop, review, and execute CSV deliverables including validation plans, risk assessments, protocols (IQ/OQ/PQ), and summary reports

• Perform validation activities for computerized systems (e.g., MES, BAS, DCS, LIMS) in compliance with regulatory standards (e.g., GAMP5, 21 CFR Part 11)

• Review and implement change controls related to computerized systems, ensuring validated state is maintained

• Evaluate and approve system configuration and changes for platforms such as Syncade, DeltaV, BAS, and other automation systems

• Investigate deviations, discrepancies, and validation issues, ensuring timely resolution and proper documentation

• Support periodic review and lifecycle management of validated systems using tools such as Kneat or equivalent

• Collaborate with QA, IT, Automation, and Engineering teams to ensure alignment on validation strategy and execution

• Ensure data integrity, audit trail review, and compliance with internal and external regulatory requirements

• Support audits and inspections by providing necessary CSV documentation and justifications

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field

• Experience in Computer System Validation within pharmaceutical, biotech, or regulated industries

• Strong knowledge of GxP, GAMP5, and 21 CFR Part 11 requirements

• Experience with validation lifecycle documentation and execution (IQ/OQ/PQ)

• Familiarity with systems such as MES (e.g., Syncade), DeltaV, BAS, LIMS, or similar platforms

• Experience with validation management tools (e.g., Kneat) is an advantage

• Strong problem-solving, analytical, and documentation skills

• Good communication skills and ability to work with cross-functional teams

Why join us

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.