CSV Laboratory 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 Laboratory Engineer is responsible for ensuring that all laboratory computerized systems comply with regulatory, quality, and data integrity requirements. This role will lead validation activities, support laboratory system upgrades, and collaborate with QC, IT, and QA teams to maintain a validated and audit‑ready state. Experience with a wide range of analytical laboratory systems is a strong advantage.

Key Responsibilities

Computerised System Validation (CSV)

• Lead end‑to‑end CSV activities including URS, risk assessments, IQ/OQ/PQ, traceability matrix, validation summary reports, and change controls.
• Ensure validation deliverables meet GMP, GAMP 5, ALCOA+, and internal quality standards.
• Maintain validated state for all laboratory systems through periodic reviews, requalification, and change management.

Laboratory System Support

• Support implementation, qualification, and lifecycle management of analytical laboratory computerized systems.
• Troubleshoot CSV-related issues and provide technical guidance to QC laboratory teams.
• Provide user training on validated systems and validation practices when required.

Upgrade & Migration Projects

• Lead and support Windows OS upgrade projects and system migration activities, ensuring compliance with data integrity and validation requirements.
• Coordinate with vendors and cross‑functional teams to ensure smooth transition without compromising system functionality or compliance.

Documentation & Compliance

• Develop and review SOPs, validation protocols, user guides, configuration documentation, and technical reports.
• Support audits and inspections by presenting validation documentation and ensuring system compliance.

Required Qualifications

• Degree in Engineering, Computer Science, Life Sciences, or related discipline.
• Minimum 3–7 years of CSV experience, preferably in GMP pharmaceutical, biopharmaceutical, or medical device laboratories.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, data integrity principles, and GMP requirements.
• Proven experience validating laboratory computerized systems.
• Strong analytical and problem‑solving abilities
• Excellent documentation and communication skills
• Ability to lead cross‑functional validation initiatives
• Strong understanding of laboratory workflows and analytical instrumentation
• Ability to work independently and mentor junior engineers

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.