Engineering Compliance Specialist
Core
Ensures Engineering operations comply with regulatory standards, procedures, and policies within the pharmaceutical industry, supporting Quality and EHS Compliance aspects.
Role type
Engineering Compliance Specialist
Builds
Regulatory compliance metrics, corrective action plans, and audit documentation for engineering systems.
Domain
Pharmaceutical manufacturing / Engineering operations
Required skills
Root cause analysis, Trackwise Investigation process, GMP, OSHA, FDA regulations, SOP development, CAPA management, audit coordination, calibration management, deviation investigation
Preferred skills
Six Sigma DMAIC, Technical writing (via careerplan.io/jobs/R5670837-engineering-compliance-specialist-at-viatris)
Technologies
Trackwise, Plateau, My University
Responsibilities
Lead root cause investigations and corrective action documentation; Generate and document Calibration alerts; Support internal and external audits for regulatory systems; Define training structure and track compliance with regulatory training requirements; Contribute to the development and revision of departmental SOPs; Provide technical expertise in resolving deviations or regulatory issues.
Seniority
Mid-Senior, hands-on IC
