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
This role supports the establishment of a biopharmaceutical manufacturing facility, leading the Computer System Validation activities across multiple systems supporting manufacturing, QC, utilities, and engineering functions. The CSV Lead will ensure that all computerized systems are validated in compliance with global and local regulatory requirements, such as GAMP 5, EU Annex 11, and 21 CFR Part 11.
Key Responsibilities
1. CSV Strategy & Planning
- Develop and implement the overall CSV Master Plan for the greenfield project, covering all phases from design through operational readiness.
- Define validation approach, deliverables, and schedule aligned with the projects CQV and automation timelines.
- Establish system inventory and classification (GxP / Non-GxP, criticality assessment) for all computerized systems.
- Coordinate with Engineering, Automation, IT, and Quality teams to ensure CSV activities are integrated into the overall project plan.
2. Execution & Documentation
- Lead and review key CSV deliverables: URS, SRA, DQ, IQ, OQ, PQ, RTM, validation summary reports.
- Ensure data integrity requirements are incorporated and verified during qualification.
- Oversee execution of validation protocols and ensure deviations are appropriately documented and resolved.
- Review vendor documentation and FAT/SAT test scripts for compliance with CSV requirements.
3. System Lifecycle Management
- Support implementation of electronic systems such as DeltaV, LIMS, Empower, BMS, EMS, CMMS, DCS, and MES.
- Define and enforce change control, periodic review, backup and disaster recovery procedures for validated systems.
- Develop templates and procedures for CSV governance, ensuring sustainability beyond the startup phase.
- Support handover to Operations and Quality for ongoing system maintenance and compliance.
4. Compliance & Quality Interface
- Ensure compliance with Client Global CSV Policy, ALCOA+ principles, Annex 11, and 21 CFR Part 11.
- Act as primary CSV subject matter expert during internal and external audits.
- Collaborate with QA to ensure deviations, CAPAs, and changes are managed per validation standards.
- Provide CSV-related input to SOPs, training, and regulatory submissions.
Required Qualifications
- Bachelors degree in Engineering, Computer Science, Life Sciences, or equivalent.
- Minimum 8-10 years of experience in Computer System Validation within the pharmaceutical or biotech industry.
- Strong knowledge of GAMP 5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.
- Proven experience leading CSV for greenfield projects or large system implementations.
- Hands-on experience with automation (DeltaV, PLC, SCADA) and/or lab systems (LIMS, Empower, CDS) preferred.
- Familiarity with cloud-based and hybrid systems validation approaches (e.g., SaaS, IaaS).
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.
