QA CSV Engineer || Pharmaceutical / Biotech Manufacturing (CAR-T)
Location: Onsite – Beerse, Belgium
The QA CSV Engineer ensures regulatory compliance of computerized systems throughout their full lifecycle (concept, implementation, operation, and retirement) within a CAR-T manufacturing environment. The role owns and governs Computerized Systems Validation (CSV) processes, ensuring alignment with global regulatory requirements and internal quality standards. The position supports audits, change management, deviation management, and cross-functional projects while acting as the subject matter expert for CSV and 21 CFR Part 11 compliance.
Requirements:
* Fluency in English
* Fluency in Dutch
* Knowledge of cGMP regulations including 21 CFR Part 11, 21 CFR Parts 210/211, EU GMP Volume 4, and Annex 11
* Experience with Computerized Systems Validation (CSV) in a GxP regulated environment
* Experience reviewing and approving validation documentation (e.g., URS, risk assessments, validation plans, test documentation)
* Experience participating in audits (internal and/or external)
* Knowledge of GAMP guidelines
Responsibilities
* Own and oversee Computerized Systems Validation (CSV) activities across the full system lifecycle
* Ensure compliance with cGMP, 21 CFR Part 11, EU GMP Annex 11, and GAMP guidelines
* Act as Process Owner for local CSV activities and maintain Validation Master Plans
* Review and approve URS, risk assessments, validation plans, test protocols, reports, and related SOPs
* Provide CSV and regulatory guidance during new system implementations
* Support change control and deviation management processes
* Evaluate system-related incidents and assess potential product quality impact
* Support and follow up on CAPA activities
* Prepare for and participate in internal and external audits and inspections
* Act as CSV subject matter expert and spokesperson during inspections
* Deliver CSV-related training within the organization
* Drive continuous improvement of validation and compliance processes
Essential Skills, Qualifications, and Experience
* Experience acting as process owner or SME for CSV or validation processes
* Experience maintaining Validation Master Plans (VMPs)
* Experience in change management and deviation management processes
* Experience evaluating incidents related to computerized systems and proposing CAPA
* Experience working in cross-functional project teams (e.g., IT, Engineering, QA)
* Knowledge of software development lifecycle (SDLC) and testing processes
* Knowledge of quality auditing principles
* Experience preparing for regulatory inspections
* Experience delivering training on regulatory or validation topics
* Experience with pharmaceutical manufacturing systems (e.g., MES, LIMS, PLCs, warehouse management systems)
* Experience with document management systems and training management systems
* Experience using validation or test management tools (e.g., qTest, KNEAT)
Interested? Apply now or send your CV to l.ormrod@panda-int.com