Engineering Compliance Specialist
Core
Ensure engineering activities comply with internal standards, industry regulations, and global pharmaceutical quality requirements through auditing, monitoring, and risk management.
Role type
Engineering Compliance Specialist
Builds
Compliant engineering processes and systems for vaccine manufacturing
Domain
Pharmaceutical manufacturing / Vaccines
Deliverable
client delivery
Required skills
CAPA Processes, Compliance Risk Management, Computerized Maintenance Management Systems (CMMS), GMP Compliance, Pharmaceutical Process Engineering, Quality Risk Assessment, Regulatory Compliance, Vendor Management
Preferred skills
Knowledge of risk management and CAPA processes
Technologies
Computerized Maintenance Management Systems (CMMS)
Responsibilities
Lead deviation and out-of-tolerance investigations end-to-end; Own the Engineering Department's audit readiness programme and act as liaison during regulatory inspections; Prepare and analyse quality metrics and trend reports; Maintain and review engineering SOPs, protocols, and compliance documentation; Participate in Quality Risk Assessments for engineering changes and projects; Support validation/qualification of engineering systems and equipment; Coach engineering personnel on GMP and compliance requirements.
Seniority
Mid-level, hands-on specialist
