QC CSV Validation 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

We are seeking a Validation Contractor to support key validation activities within the QC Laboratory. This role involves both software upgrade validation and the decommissioning of legacy computerized systems in a GMP-regulated laboratory environment.

Key Responsibilities

• Plan and execute validation activities associated with the software upgrade of a laboratory analytical system. 
• Develop and review validation documentation including URS, risk assessments, protocols (IQ/OQ/PQ), and summary reports in alignment with current regulatory requirements. 
• Collaborate with QC and IT teams to ensure accurate integration of system requirements and compliance with data integrity expectations. 
• Lead or support the decommissioning of computerized systems used within the QC lab. 
• Ensure proper archival of data and documentation during decommissioning, including backup, verification, and system retirement in accordance with company procedures.
• Maintain compliance with cGMP, GDP, and ALCOA+ principles throughout all validation tasks.
• Liaise with internal stakeholders to align validation strategy with project timelines and quality expectations.

Required Qualifications

• Bachelors Degree in Life Sciences, Engineering, Computer Science, or a related discipline. 
• Proven experience in validation of computerized systems in a GMP laboratory or manufacturing environment.
• Strong understanding of GAMP 5, FDA 21 CFR Part 11, and Annex 11 requirements. 
• Experience in system decommissioning and data migration strategies. 
• Excellent documentation, organizational, and communication skills. 
• Ability to work independently and collaboratively with cross-functional teams. 

Why join us?

• 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.